Trial Outcomes & Findings for Ashwagandha Pharmacokinetics Study in Older Adults (NCT NCT06171724)

Last Updated: 2026-04-09

Results Overview

After oral administration of Shoden (240 or 480 mg), plasma concentrations of withanolides will be measured in plasma samples obtained over a 48-hour period, using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS) to determine pharmacokinetic parameters.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

11 participants

Primary outcome timeframe

For each study period, a 48-hour post-administration period (15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 48 hours)

Results posted on

2026-04-09

Participant Flow

Participants were recruited from April 2024 until September 2024.

Participant milestones

Participant milestones
Measure	Shoden 240 mg First, Then Shoden 480 mg At pharmacokinetics visit 1, participants receive a single dose of 240 mg Shoden, administered as two 120 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 240 mg per day. After a 2- to 4-week washout period, participants attend pharmacokinetics visit 2, during which participants receive a single dose of 480 mg Shoden, administered as two 240 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 480 mg per day. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg First, Then Shoden 240 mg At pharmacokinetics visit 1, participants receive a single dose of 480 mg Shoden, administered as two 240 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 480 mg per day. After a 2- to 4-week washout period, participants attend pharmacokinetics visit 2, during which participants receive a single dose of 240 mg Shoden, administered as two 120 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 240 mg per day. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.
Overall Study STARTED	3	4
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Shoden 240 mg First, Then Shoden 480 mg At pharmacokinetics visit 1, participants receive a single dose of 240 mg Shoden, administered as two 120 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 240 mg per day. After a 2- to 4-week washout period, participants attend pharmacokinetics visit 2, during which participants receive a single dose of 480 mg Shoden, administered as two 240 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 480 mg per day. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg First, Then Shoden 240 mg At pharmacokinetics visit 1, participants receive a single dose of 480 mg Shoden, administered as two 240 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 480 mg per day. After a 2- to 4-week washout period, participants attend pharmacokinetics visit 2, during which participants receive a single dose of 240 mg Shoden, administered as two 120 mg capsules. Forty-eight hours later, participants receive a 35-day supply of Shoden, administered at 240 mg per day. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.
Overall Study Adverse Event	1	1
Overall Study Mild anemia noted on baseline labs at pharmacokinetics visit 1.	1	1
Overall Study Mild anemia noted on baseline labs at pharmacokinetics visit 2	0	1

Baseline Characteristics

Ashwagandha Pharmacokinetics Study in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=7 Participants Participants were randomized to receive either 240 mg Shoden first, then 480 mg Shoden, or 480 mg Shoden first, then 240 mg Shoden. Because all study participants were randomized to receive all interventions, baseline measures are presented for all study participants. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.
Age, Continuous	69.7 years STANDARD_DEVIATION 3.8 • n=36 Participants
Sex: Female, Male Female	5 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=36 Participants
Race (NIH/OMB) White	7 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=36 Participants
Region of Enrollment United States	7 participants n=36 Participants
Body Mass Index	23.9 kg/m^2 STANDARD_DEVIATION 2.7 • n=36 Participants
Systolic Blood Pressure	134.6 mmHg STANDARD_DEVIATION 14.7 • n=36 Participants
Diastolic Blood Pressure	73.0 mmHg STANDARD_DEVIATION 5.5 • n=36 Participants
Oral Temperature	97.7 degrees Farenheit STANDARD_DEVIATION 0.2 • n=36 Participants

PRIMARY outcome

Timeframe: For each study period, a 48-hour post-administration period (15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 48 hours)

Population: Sufficient blood samples to construct pharmacokinetic curves were only collected for two participants administered 240 mg Shoden and three participants administered 480 mg Shoden. Reasons for not collecting sufficient blood samples for all participants included inability to place intravenous catheter (n=1), mild anemia on 0-hour labs pre-Shoden administration (n=3), and gastrointestinal side effects during the visit (n=1).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=2 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=3 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration Withaferin A	3.02 ng/ml Standard Deviation 0.76	13.69 ng/ml Standard Deviation 7.36	—	—
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration Isomer of 4-oxo Withaferin A	46.82 ng/ml Standard Deviation 1.66	187.62 ng/ml Standard Deviation 120.77	—	—
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration Sominone	10.24 ng/ml Standard Deviation 6.48	33.45 ng/ml Standard Deviation 14.42	—	—
Maximum Plasma Concentration (Cmax) of Withanolides After Shoden Administration Isomer of 2,3-Didehydrosomnifericin	19.62 ng/ml Standard Deviation 16.04	35.28 ng/ml Standard Deviation 17.60	—	—

SECONDARY outcome

The time of maximum (tmax) of withanolides over the first 48 hours post-Shoden administration will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=2 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=3 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Time of Maximum Concentration of Withanolides After Shoden Administration Sominone	5.50 hours Standard Deviation 0.71	5.67 hours Standard Deviation 0.58	—	—
Time of Maximum Concentration of Withanolides After Shoden Administration Isomer of 2,3-Didehydrosomnifericin	0.75 hours Standard Deviation 0.35	2.00 hours Standard Deviation 0.50	—	—
Time of Maximum Concentration of Withanolides After Shoden Administration Withaferin A	0.88 hours Standard Deviation 0.18	1.25 hours Standard Deviation 0.66	—	—
Time of Maximum Concentration of Withanolides After Shoden Administration Isomer of 4-oxo Withaferin A	3.25 hours Standard Deviation 0.35	2.83 hours Standard Deviation 0.58	—	—

SECONDARY outcome

The half-life (t1/2) of withanolides will be calculated using liquid chromatography coupled to multiple reaction monitoring mass spectrometry (LC-MRM-MS).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=2 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=3 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Half-life of Withanolides After Shoden Administration Withaferin A	2.0 hours Standard Deviation 0.0	5.0 hours Standard Deviation 3.1	—	—
Half-life of Withanolides After Shoden Administration Isomer of 4-oxo withaferin A	18.1 hours Standard Deviation 4.8	24.1 hours Standard Deviation 12.3	—	—
Half-life of Withanolides After Shoden Administration Sominone	4.7 hours Standard Deviation 2.4	7.7 hours Standard Deviation 4.9	—	—
Half-life of Withanolides After Shoden Administration Isomer of 2,3-didehydrosomnifericin	6.2 hours Standard Deviation 6.1	10.3 hours Standard Deviation 3.1	—	—

SECONDARY outcome

Timeframe: For each study period, steady state concentration will be collected during week 4 following four weeks' daily use of Shoden.

Population: The 4-week study period where participants were administered 480 mg Shoden every day was completed by only 3/5 participants who started that period. Two participants experienced gastrointestinal side effects and stopped taking the intervention within the first two weeks. Therefore, steady-state samples at four weeks were not collected for those participants.

Concentration (ng/ml) of selected withanolides in plasma after four weeks' use

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=3 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Steady-state Concentration of Selected Withanolides in Plasma Withaferin A	1.13 ng/ml Standard Deviation 0.60	2.35 ng/ml Standard Deviation 1.07	—	—
Steady-state Concentration of Selected Withanolides in Plasma Isomer of 4-oxo Withaferin A	24.11 ng/ml Standard Deviation 7.13	41.94 ng/ml Standard Deviation 19.36	—	—
Steady-state Concentration of Selected Withanolides in Plasma Sominone	14.93 ng/ml Standard Deviation 10.89	23.40 ng/ml Standard Deviation 2.67	—	—
Steady-state Concentration of Selected Withanolides in Plasma Isomer of 2,3-Didehydrosomnifericin	13.35 ng/ml Standard Deviation 1.84	36.91 ng/ml Standard Deviation 19.50	—	—

SECONDARY outcome

Timeframe: For each study period, urine collected over the first 12 hours post-Shoden administration.

The concentration (ng/ml) of withanolides in urine will be measured in a pooled urine sample over 12 hours post-Shoden administration.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=2 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=3 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Urine Concentration of Withanolides After Shoden Administration Sominone as Phase II conjugates	61.7 micrograms excreted in 12 hours Standard Deviation 29.2	76.8 micrograms excreted in 12 hours Standard Deviation 25.2	—	—
Urine Concentration of Withanolides After Shoden Administration Free withaferin A	133.5 micrograms excreted in 12 hours Standard Deviation 115.3	172.9 micrograms excreted in 12 hours Standard Deviation 151.1	—	—
Urine Concentration of Withanolides After Shoden Administration Free isomer of 4-oxo-withaferin A	95.8 micrograms excreted in 12 hours Standard Deviation 17.9	230.3 micrograms excreted in 12 hours Standard Deviation 73.7	—	—
Urine Concentration of Withanolides After Shoden Administration Isomer of 4-oxo-withaferin A as Phase II conjugates	25.5 micrograms excreted in 12 hours Standard Deviation 0.8	24.0 micrograms excreted in 12 hours Standard Deviation 86.2	—	—
Urine Concentration of Withanolides After Shoden Administration Free isomer of 2,3-didehydrosomnifericin	234.8 micrograms excreted in 12 hours Standard Deviation 139.9	663.1 micrograms excreted in 12 hours Standard Deviation 222.6	—	—

SECONDARY outcome

Timeframe: For each study period, electrocardiography will be assessed at 0 and 7 hours post-Shoden administration. For pharmacokinetics visits that were halted early, ECG was collected at 24 hours.

Resting electrocardiography will be measured using a ten-lead electrocardiogram at the zero-minutes timepoint and 7 hours post-Shoden administration. Electrocardiogram changes will be assessed and alternative clinical explanations considered, in order to determine if any changes are attributable to the study intervention. The number of participants with abnormal ECG readings at 7 hours compared to baseline will be reported.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=4 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Number of Participants With Abnormal ECG Readings (7 Hours)	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: For each study period, electrocardiography will be assessed at 0 and 4 weeks post-Shoden administration.

Resting electrocardiography will be measured using a ten-lead electrocardiogram at the zero-minutes timepoint and 4-weeks post-Shoden administration. Electrocardiogram changes will be assessed and alternative clinical explanations considered, in order to determine if any changes are attributable to the study intervention. The number of participants with abnormal ECG readings at 4 weeks compared to baseline will be reported.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Number of Participants With Abnormal ECG Readings (4 Weeks)	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: For each study period, liver function will be assessed at 0 and 10 hours post-Shoden administration. For pharmacokinetics visits that were halted early, safety labs were collected at 24 hours.

A comprehensive metabolic panel will measure alanine aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=4 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in ALT (10 Hours)	0 U/L Standard Deviation 2.2	-1 U/L Standard Deviation 1.7	—	—

SECONDARY outcome

Timeframe: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in ALT (4 Weeks)	5.3 U/L Standard Deviation 8.5	-0.4 U/L Standard Deviation 3.6	—	—

SECONDARY outcome

A comprehensive metabolic panel will measure aspartate aminotransferase and in units per liter as a marker of liver function. Enzyme levels falling outside the normal range will be compared to baseline levels, and alternative clinical explanations considered, in order to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=4 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in AST (10 Hours)	-0.8 U/L Standard Deviation 2.1	-1.2 U/L Standard Deviation 1.6	—	—

SECONDARY outcome

Timeframe: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in AST (4 Weeks)	3 U/L Standard Deviation 3	0.8 U/L Standard Deviation 1.3	—	—

SECONDARY outcome

A comprehensive metabolic panel will measure creatinine as a marker of kidney function. Each parameter falling outside the normal range (0.5 to 1.2 milligrams per deciliter) will be compared to baseline values. If elevations are observed, alternative clinical explanations will be considered to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to 10-hours post-Shoden administration for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=4 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Creatinine (10 Hours)	0.02 mg/dL Standard Deviation 0.04	0.002 mg/dL Standard Deviation 0.06	—	—

SECONDARY outcome

Timeframe: For each study period, liver function will be assessed at 0 and 4 weeks post-Shoden administration.

A comprehensive metabolic panel will measure creatinine as a marker of kidney function. Each parameter falling outside the normal range (0.5 to 1.2 milligrams per deciliter) will be compared to baseline values. If elevations are observed, alternative clinical explanations will be considered to determine if elevations are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Creatinine (4 Weeks)	0.05 mg/dL Standard Deviation 0.07	0.10 mg/dL Standard Deviation 0.07	—	—

SECONDARY outcome

Timeframe: For each study period, thyroid-stimulating hormone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

Thyroid-stimulating hormone will be measured in units of milli-international units per liter as a marker of thyroid function. Any changes in hormone levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hormone levels are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Thyroid-stimulating Hormone (4 Weeks)	-0.3 mIU/L Standard Deviation 1.4	-0.3 mIU/L Standard Deviation 0.3	—	—

SECONDARY outcome

Timeframe: For each study period, testosterone will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

Population: Data is presented only for participants who completed at least one full study period for one of the two intervention doses.

Testosterone will be measured in units of nanograms per deciliter. Any changes in hormone levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in testosterone levels are attributable to the study intervention. Changes in testosterone will be analyzed by sex, by dose.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=1 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=2 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg n=1 Participants Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg n=4 Participants Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Testosterone (4 Weeks)	113 ng/dL Standard Deviation NA There was only data for one male participant at this dose.	-1.5 ng/dL Standard Deviation 3.5	179 ng/dL Standard Deviation NA There was only data for one male participant at this dose.	-1.5 ng/dL Standard Deviation 2.9

SECONDARY outcome

Timeframe: For each study period, white blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

White blood cells will be measured in units of cells per cubic millimeter. Any changes in red blood cell levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in red blood cells are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean White Blood Cell Count (4 Weeks)	-0.5 10^3 cells/microliter Standard Deviation 0.5	0.0 10^3 cells/microliter Standard Deviation 1.3	—	—

SECONDARY outcome

Timeframe: For each study period, red blood cells will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

Red blood cells will be measured in units of cells per cubic millimeter. Any changes in red blood cell levels will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in red blood cells are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Red Blood Cell Count (4 Weeks)	0.1 10^6 cells/µL Standard Deviation 0.2	-0.5 10^6 cells/µL Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: For each study period, hemoglobin will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

Hemoglobin will be measured in grams per deciliter. Any changes in hemoglobin will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hemoglobin are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Hemoglobin (4 Weeks)	0.3 g/dL Standard Deviation 0.6	0.04 g/dL Standard Deviation 0.7	—	—

SECONDARY outcome

Timeframe: For each study period, hematocrit will be assessed at 0 minutes post-Shoden administration and four weeks post-Shoden administration.

Hematocrit will be measured in percent. Any changes in hematocrit will be compared to baseline levels. Alternative clinical explanations will be considered in order to determine if any changes in hematocrit are attributable to the study intervention. Changes in laboratory outcomes from the baseline visit to the four-week follow-up visit for each study period will be presented using descriptive statistics (e.g., means and standard deviations, frequency and percent).

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=3 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=5 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Mean Change in Hematocrit (4 Weeks)	1.1 percentage of total blood volume Standard Deviation 1.8	1.2 percentage of total blood volume Standard Deviation 2.2	—	—

SECONDARY outcome

Timeframe: For each study period, prior to the pharmacokinetics visit and prior to the four-week follow-up visit

The feasibility of administering REDCap surveys will be assessed by calculating the percentage of administered questionnaires that are returned and fully completed by participants, with feasibility defined as at least 80% of all administered questionnaires returned and completed.

Outcome measures

Outcome measures
Measure	Shoden 240 mg n=5 Participants Participants will receive a single dose of 240 mg Shoden, administered as two 120 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Shoden 480 mg n=6 Participants Participants will receive a single dose of 480 mg Shoden, administered as two 240 mg capsules, at pharmacokinetics visit 1 or 2 depending on their sequence group. Blood will be collected at 17 timepoints over 48 hours. Shoden: Shoden® powder is a commercial, dried 70% ethanolic extract of Withania somnifera (ashwagandha, WS) root and leaf, standardized to 35% withanolide glycosides. Shoden® powder is manufactured by Arjuna Natural Pvt Ltd, based in Kochi, Kerala, India.	Male Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all male participants who completed that four-week period.	Female Participants - 480 mg Forty-eight hours after the pharmacokinetics visit where participants were administered a single dose of 480 mg Shoden, participants were administered 480 mg Shoden daily for four weeks. This arm includes all female participants who completed that four-week period.
Percentage of REDCap Surveys Completed	88.9 percentage of questionnaires completed	90.9 percentage of questionnaires completed	—	—

Adverse Events

Shoden 240 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Shoden 480 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Alex Speers

Oregon Health & Science University

Phone: 5034185896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place