Trial Outcomes & Findings for RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19 (NCT NCT04667247)

Results Overview

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

54 participants

Primary outcome timeframe

14 days

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Mushrooms Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Overall Study STARTED	28	26
Overall Study COMPLETED	28	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Mushrooms Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.	Total n=50 Participants Total of all reporting groups
Age, Continuous	43.27 years STANDARD_DEVIATION 11.098 • n=99 Participants	47.71 years STANDARD_DEVIATION 17.269 • n=107 Participants	45.40 years STANDARD_DEVIATION 14.417 • n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants	22 Participants n=107 Participants	42 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	26 participants n=99 Participants	24 participants n=107 Participants	50 participants n=206 Participants
Total Protein Normal	22 Participants n=99 Participants	23 Participants n=107 Participants	45 Participants n=206 Participants
Albumin Normal	25 Participants n=99 Participants	23 Participants n=107 Participants	48 Participants n=206 Participants
Alkaline Phosphatase Normal	24 Participants n=99 Participants	23 Participants n=107 Participants	47 Participants n=206 Participants
AST Normal	25 Participants n=99 Participants	24 Participants n=107 Participants	49 Participants n=206 Participants
ALT Normal	23 Participants n=99 Participants	23 Participants n=107 Participants	46 Participants n=206 Participants
Total Bilirubin Normal	26 Participants n=99 Participants	24 Participants n=107 Participants	50 Participants n=206 Participants
eGFR Normal	21 Participants n=99 Participants	14 Participants n=107 Participants	35 Participants n=206 Participants
Prothrombin Time Normal	24 Participants n=99 Participants	21 Participants n=107 Participants	45 Participants n=206 Participants
APTT Normal	22 Participants n=99 Participants	19 Participants n=107 Participants	41 Participants n=206 Participants
ESR Normal	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
CRP Normal	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
LDH Normal	13 Participants n=99 Participants	9 Participants n=107 Participants	22 Participants n=206 Participants

PRIMARY outcome

Timeframe: 14 days

Population: All participants who were normal at baseline were also normal at day 14, so Chi-square statistic could not be computed.

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=22 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Total Protein Normal to Abnormal Transition	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=25 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Albumin Normal to Abnormal Transition	4 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=24 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Alkaline Phosphatase Normal to Abnormal Transition	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=25 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
AST Normal to Abnormal Transition	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=23 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
ALT Normal to Abnormal Transition	4.3 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Bilirubin Normal to Abnormal Transition	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=21 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=14 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Adj. EGFR Normal to Abnormal Transition	28.6 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=23 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=21 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Prothrombin Time Normal to Abnormal Transition	0 percentage of participants	14.3 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=22 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=20 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
APTT Normal to Abnormal Transition	4.5 percentage of participants	5.0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=20 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=14 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
ESR Normal to Abnormal Transition	0 percentage of participants	14.3 percentage of participants

PRIMARY outcome

Timeframe: 14 days

Population: Chi-square statistic could not be computed because all participants who were normal at baseline were also normal at day 14.

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=13 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=14 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
CRP Normal to Abnormal Transition	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 14 days

We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

Outcome measures

Outcome measures
Measure	Mushrooms n=13 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=8 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
LDH Normal to Abnormal Transition	46.2 percentage of participants	37.5 percentage of participants

SECONDARY outcome

Timeframe: 14 days

comparison of the Total Bilirubin of baseline laboratory data with end-of-treatment labs

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Total Bilirubin Baseline	0.4215 mg/dL Standard Deviation 0.19164	0.3650 mg/dL Standard Deviation 0.13197
Total Bilirubin Day 14	0.5469 mg/dL Standard Deviation 0.24245	0.4216 mg/dL Standard Deviation 0.18950

SECONDARY outcome

Timeframe: 14 days

comparison of the prothrombin time of baseline laboratory data with end-of-treatment labs

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Prothrombin Time Baseline	11.515 sec Standard Deviation 0.7656	11.448 sec Standard Deviation 0.9258
Prothrombin Time Day 14	11.342 sec Standard Deviation 0.5687	11.342 sec Standard Deviation 1.1477

SECONDARY outcome

Timeframe: 14 days

Comparison of the aspartate transaminase of baseline laboratory data with end-of-treatment labs

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Aspartate Aminotransferase (AST) Baseline	23.50 U/L Standard Deviation 7.814	22.92 U/L Standard Deviation 6.406
Aspartate Aminotransferase (AST) Day 14	20.73 U/L Standard Deviation 4.944	20.54 U/L Standard Deviation 4.403

SECONDARY outcome

Timeframe: 14 days

The safety of the study medication will also assessed by a comparison of the alanine transaminase of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients)

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Alanine Transaminase (ALT) Baseline	28.15 U/L Standard Deviation 21.780	22.92 U/L Standard Deviation 10.902
Alanine Transaminase (ALT) Day 14	22.62 U/L Standard Deviation 11.876	19.79 U/L Standard Deviation 7.163

SECONDARY outcome

Timeframe: 14 days

comparing Albumin of baseline laboratory data with end-of-treatment labs

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Albumin Baseline	4.565 U/L Standard Deviation 0.3610	4.517 U/L Standard Deviation 0.2729
Albumin Day 14	4.638 U/L Standard Deviation 0.2899	4.558 U/L Standard Deviation 0.2933

SECONDARY outcome

Timeframe: 14 days

comparing the Alkaline Phosphatase of baseline laboratory data with end-of-treatment labs

Outcome measures

Outcome measures
Measure	Mushrooms n=25 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Alkaline Phosphatase Baseline	75.64 U/L Standard Deviation 38.583	76.29 U/L Standard Deviation 22.894
Alkaline Phosphatase Day 14	68.50 U/L Standard Deviation 20.090	77.54 U/L Standard Deviation 19.797

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum Lactate Dehydrogenase level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Lactate Dehydrogenase Baseline	186.08 U/L Standard Deviation 29.020	195.38 U/L Standard Deviation 41.484
Lactate Dehydrogenase Day 14	195.77 U/L Standard Deviation 33.448	207.70 U/L Standard Deviation 37.920

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the serum C-Reactive Protein level of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
C-Reactive Protein Baseline	0.9437 mg/dL Standard Deviation 1.15630	0.5452 mg/dL Standard Deviation 0.38384
C-Reactive Protein Day 14	0.3325 mg/dL Standard Deviation 0.47883	0.3686 mg/dL Standard Deviation 0.44187

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by changes in the SARS CoV-2 viral loads among mid-turbinate nasal swabs taken on days 0, 4, 7 and 14.

Outcome measures

Outcome measures
Measure	Mushrooms n=23 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=21 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Mid-turbinate SARS CoV-2 Viral Load Baseline	15.2895 copies per mL Standard Deviation 4.93549	14.9429 copies per mL Standard Deviation 4.65693
Mid-turbinate SARS CoV-2 Viral Load Day 7	27.7164 copies per mL Standard Deviation 9.02866	32.3462 copies per mL Standard Deviation 7.83317
Mid-turbinate SARS CoV-2 Viral Load Day 14	37.7235 copies per mL Standard Deviation 5.14676	37.4067 copies per mL Standard Deviation 4.78418

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the Adj. EGFR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).

Outcome measures

Outcome measures
Measure	Mushrooms n=23 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Adj. EGFR Baseline	111.93848626354 mL/min Standard Deviation 20.474674486202	101.72611717162 mL/min Standard Deviation 22.886437908934
Adj. EGFR Day 14	104.27777159545 mL/min Standard Deviation 20.422794275258	103.86989833636 mL/min Standard Deviation 21.260168489030

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the APTT of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
APTT Baseline	32.377 sec Standard Deviation 3.0971	32.233 sec Standard Deviation 2.9762
APTT Day 14	32.108 sec Standard Deviation 2.8652	31.513 sec Standard Deviation 3.0824

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the INR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients). The INR is a result of a blood test that measures how long it takes for blood to clot, also known as the prothrombin time (PT). The INR is calculated by comparing the PT to the mean normal prothrombin time (MNPT).

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=23 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
INR Baseline	1.073 ratio Standard Deviation 0.0604	1.048 ratio Standard Deviation 0.0593
INR Day 14	1.054 ratio Standard Deviation 0.0588	1.033 ratio Standard Deviation 0.0565

SECONDARY outcome

Timeframe: 14 days

A secondary exploratory objective will be to evaluate COVID-19 severity among subjects in each of the two medication arms, compared with placebo, as ascertained by comparing the ESR of baseline laboratory data with end-of-treatment labs or on hospital admission labs (for hospitalized patients).

Outcome measures

Outcome measures
Measure	Mushrooms n=24 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=19 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
ESR Baseline	12.54 mm/hr Standard Deviation 9.288	14.89 mm/hr Standard Deviation 13.780
ESR Day 14	11.13 mm/hr Standard Deviation 13.766	12.68 mm/hr Standard Deviation 10.409

SECONDARY outcome

Timeframe: 14 days

Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and counting the total number of symptoms present. scores of 1 or more were considered to be present.

Outcome measures

SECONDARY outcome

Timeframe: 14 days

Symptom severity was assessed via a daily questionnaire across Days 0-14, where participants rated their symptoms on a scale of 0 (none or absent) to 3 (severe). A composite measure was created for each day, based on the 12 symptoms most commonly associated with COVID-19 (fever, fatigue, muscle aches, shortness of breath, shortness of breath upon exertion, cough, sore throat, stuffy nose, runny nose, loss of taste, loss of smell, headache), and summing the total symptom severities. Higher symptom severities indicates a worse outcome. The minimum and maximum were: 0 to 36, respectively.

Outcome measures

Outcome measures
Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Symptom Severities Baseline (Day 0)	13.6538 units on a scale Standard Deviation 6.62687	11.0833 units on a scale Standard Deviation 4.26224
Symptom Severities Day 1	10.4615 units on a scale Standard Deviation 5.57301	10.4167 units on a scale Standard Deviation 5.53186
Symptom Severities Day 2	8.8077 units on a scale Standard Deviation 4.63050	9.1667 units on a scale Standard Deviation 5.18079
Symptom Severities Day 3	7.2692 units on a scale Standard Deviation 4.17188	8.8333 units on a scale Standard Deviation 5.44272
Symptom Severities Day 4	6.0000 units on a scale Standard Deviation 4.40000	8.4583 units on a scale Standard Deviation 5.94159
Symptom Severities Day 5	5.6538 units on a scale Standard Deviation 4.36296	7.2917 units on a scale Standard Deviation 5.08604
Symptom Severities Day 6	5.7308 units on a scale Standard Deviation 4.26669	7.3750 units on a scale Standard Deviation 5.37152
Symptom Severities Day 7	4.8462 units on a scale Standard Deviation 3.94657	6.4167 units on a scale Standard Deviation 5.03826
Symptom Severities Day 8	4.1154 units on a scale Standard Deviation 3.65871	5.1667 units on a scale Standard Deviation 4.54606
Symptom Severities Day 9	3.8462 units on a scale Standard Deviation 3.71691	4.1250 units on a scale Standard Deviation 3.53015
Symptom Severities Day 10	3.4231 units on a scale Standard Deviation 3.63509	3.8750 units on a scale Standard Deviation 3.46802
Symptom Severities Day 11	2.4615 units on a scale Standard Deviation 3.03619	3.7083 units on a scale Standard Deviation 4.01605
Symptom Severities Day 12	2.1538 units on a scale Standard Deviation 3.19615	3.5652 units on a scale Standard Deviation 3.34156
Symptom Severities Day 14	1.6154 units on a scale Standard Deviation 2.65446	2.9167 units on a scale Standard Deviation 3.53758
Symptom Severities Day 13	1.9615 units on a scale Standard Deviation 2.77821	3.2500 units on a scale Standard Deviation 3.74456

Adverse Events

Mushrooms

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mushrooms n=26 participants at risk Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 participants at risk Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Vascular disorders high blood pressure	3.8% 1/26 • Number of events 12 • 14 days	4.2% 1/24 • Number of events 2 • 14 days
Metabolism and nutrition disorders High Glucose	0.00% 0/26 • 14 days	4.2% 1/24 • Number of events 1 • 14 days

Additional Information

Gordon Saxe, M.D./Ph.D.

Krupp Center for Integrative Research, University of California San Diego

Phone: 6195435765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mushrooms n=26 Participants Fomitopsis officinalis and Trametes versicolor FoTv: 8 capsules three times a day for 14 consecutive days.	Placebo n=24 Participants Organic brown rice FoTv: 8 capsules three times a day for 14 consecutive days.
Symptom Count Day 10	2.3077 Total Number of Symptoms Standard Deviation 2.27630	3.0833 Total Number of Symptoms Standard Deviation 2.68517
Symptom Count Day 11	1.6923 Total Number of Symptoms Standard Deviation 2.07402	2.7917 Total Number of Symptoms Standard Deviation 2.81269
Symptom Count Day 12	1.3077 Total Number of Symptoms Standard Deviation 1.56893	2.6522 Total Number of Symptoms Standard Deviation 2.26853
Symptom Count Day 13	1.1538 Total Number of Symptoms Standard Deviation 1.48842	2.3750 Total Number of Symptoms Standard Deviation 2.42832
Symptom Count Day 14	1.1154 Total Number of Symptoms Standard Deviation 1.65715	2.1667 Total Number of Symptoms Standard Deviation 2.23931
Symptom Count Baseline (Day 0)	7.2308 Total Number of Symptoms Standard Deviation 2.30318	6.8750 Total Number of Symptoms Standard Deviation 1.98500
Symptom Count Day 1	6.2692 Total Number of Symptoms Standard Deviation 2.50691	6.7083 Total Number of Symptoms Standard Deviation 2.49311
Symptom Count Day 2	5.6154 Total Number of Symptoms Standard Deviation 2.36773	6.1667 Total Number of Symptoms Standard Deviation 2.86913
Symptom Count Day 3	4.9615 Total Number of Symptoms Standard Deviation 2.76378	5.7083 Total Number of Symptoms Standard Deviation 2.83578
Symptom Count Day 4	3.8077 Total Number of Symptoms Standard Deviation 2.41693	5.2500 Total Number of Symptoms Standard Deviation 2.95252
Symptom Count Day 5	3.5385 Total Number of Symptoms Standard Deviation 2.24910	5.0000 Total Number of Symptoms Standard Deviation 3.20326
Symptom Count Day 6	3.5000 Total Number of Symptoms Standard Deviation 2.21359	4.5417 Total Number of Symptoms Standard Deviation 2.57039
Symptom Count Day 7	3.1538 Total Number of Symptoms Standard Deviation 2.27495	4.1667 Total Number of Symptoms Standard Deviation 2.68112
Symptom Count Day 8	2.8077 Total Number of Symptoms Standard Deviation 2.28069	3.6250 Total Number of Symptoms Standard Deviation 2.85615
Symptom Count Day 9	2.4615 Total Number of Symptoms Standard Deviation 2.12096	3.1667 Total Number of Symptoms Standard Deviation 2.64849