Trial Outcomes & Findings for Three Arm Trial of Immune Effects of Echinacea (NCT NCT01129128)

NCT ID: NCT01129128

Last Updated: 2012-06-21

Results Overview

Highest level of TNF alpha while taking study medication

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

1-10 days after starting study medication

Results posted on

2012-06-21

Participant Flow

Healthy adult volunteers enrolled from May 2010 through March 2011

Participant milestones

Participant milestones
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Study STARTED	22	22	23
Overall Study COMPLETED	19	18	19
Overall Study NOT COMPLETED	3	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Study Lost to Follow-up	2	2	1
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	0	1	3
Overall Study Physician Decision	1	0	0

Baseline Characteristics

Three Arm Trial of Immune Effects of Echinacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=23 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=99 Participants	22 Participants n=107 Participants	23 Participants n=206 Participants	67 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age Continuous	34.1 years STANDARD_DEVIATION 10.6 • n=99 Participants	35.1 years STANDARD_DEVIATION 13.5 • n=107 Participants	28.2 years STANDARD_DEVIATION 8.0 • n=206 Participants	32.4 years STANDARD_DEVIATION 13.1 • n=7 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	14 Participants n=107 Participants	17 Participants n=206 Participants	47 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	8 Participants n=107 Participants	6 Participants n=206 Participants	20 Participants n=7 Participants
Region of Enrollment United States	22 participants n=99 Participants	22 participants n=107 Participants	23 participants n=206 Participants	67 participants n=7 Participants

PRIMARY outcome

Timeframe: 1-10 days after starting study medication

Population: Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.

Highest level of TNF alpha while taking study medication

Outcome measures

Outcome measures
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products
Peak Level of TNF Alpha	436 pg/ml Standard Deviation 510	1467 pg/ml Standard Deviation 2330	721 pg/ml Standard Deviation 1272

SECONDARY outcome

Timeframe: 1-10 days after starting study medication

Population: Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.

Highest level of IL-6 while taking study medication

Outcome measures

Outcome measures
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products
Peak Level IL-6	16296 pg/ml Standard Deviation 37448	44901 pg/ml Standard Deviation 79868	28526 pg/ml Standard Deviation 61921

SECONDARY outcome

Timeframe: 1-10 days after starting study medication

Population: Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.

Highest level of Interferon gamma while taking study medication

Outcome measures

Outcome measures
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products
Peak Level Interferon Gamma	74 pg/ml Standard Deviation 122	146 pg/ml Standard Deviation 321	121 pg/ml Standard Deviation 292

SECONDARY outcome

Timeframe: 1-10 days after starting study medication

Population: Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.

Highest level of IL-2 while taking study medication

Outcome measures

Outcome measures
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products
Peak Level IL-2	82 pg/ml Standard Deviation 79	148 pg/ml Standard Deviation 321	68 pg/ml Standard Deviation 64

SECONDARY outcome

Timeframe: 1- 30 days after starting study medication

Population: Participants who received at least one dose of study medication

Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared

Outcome measures

Outcome measures
Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 Participants Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 Participants Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 Participants Inert liquid that is similar in appearance and taste to the active Echinacea products
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	14 participants	18 participants	16 participants

Adverse Events

Commercially Available Echinacea Product #1 (5 ml/Dose)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Commercially Available Echinacea Product #2 (1 ml/Dose)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

James A Taylor, MD

University of Washington

Phone: 206-616-1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Commercially Available Echinacea Product #1 (5 ml/Dose) n=22 participants at risk Echinacea purpurea product; 5 ml dose administered three times daily for 10 days	Commercially Available Echinacea Product #2 (1 ml/Dose) n=22 participants at risk Echinacea purpurea product; 1 ml dose administered three times daily for 10 days	Placebo n=22 participants at risk Inert liquid that is similar in appearance and taste to the active Echinacea products
Gastrointestinal disorders Abdominal pain/cramps	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Appetite: decreased	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Appetite: increased	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	0.00% 0/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders constipation	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Diarrhea	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	0.00% 0/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Dry mouth	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Gas/indigestion	27.3% 6/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Gastrointestinal disorders Nausea	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Metabolism and nutrition disorders Thirst: increased	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	0.00% 0/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Nervous system disorders Headache	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	22.7% 5/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	27.3% 6/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Psychiatric disorders Anxiety	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Psychiatric disorders Depression	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
General disorders Drowsiness/sedation	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
General disorders Sleep: excessive	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
General disorders Sleep: insomnia, restless	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
General disorders Weakness/fatigue	22.7% 5/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.7% 5/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	31.8% 7/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	36.4% 8/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Skin and subcutaneous tissue disorders Rash/hives	13.6% 3/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	0.00% 0/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	4.5% 1/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 2/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	22.7% 5/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.	18.2% 4/22 • day 1 (first dose of study medication) through day 30 Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.