Immunologic Effects of Echinacea

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00860795
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The goal of this study is to determine if Echinacea purpurea stimulates the immune system. For the study, 20 healthy adults will be randomized to receive Echinacea purpurea or placebo for 10 days. Blood will be drawn to assess immune markers just before beginning the study medication, during the 10 day course of medication and after completing the course of medication. It is postulated that adults receiving the Echinacea will have evidence of immune stimulation and those receiving placebo will not.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infections	Biological: Echinacea purpurea; Drug: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Study of the Immunologic Effects of Echinacea Purpurea in Adults
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Echinacea	Biological: Echinacea purpurea; Echinacea purpurea 100 mg/ml, 25 ml daily in 2 divided doses for 10 days
Placebo Comparator: placebo	Drug: placebo; placebo 25 ml daily in 2 divided doses for 10 days

Outcome Measures

Primary Outcome Measures

1. Maximal Level of Tumor Necrosis Factor Alpha (pg/ml) [10 days]

   tumor necrosis factor alpha NK cells and evidence of CD25/69 activation

Secondary Outcome Measures

1. Maximal Levels of Interferon Alpha (pg/ml) [10 days]

   interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

2. Maximal CD25/69 Activation (% of NK CD25/69+ Cells) [10 days]

   NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation

3. Adverse Effects [30 days]

4. Maximal Levels of Interleukin 2 (pg/ml) [10 days]

   interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

5. Maximal Levels of Interleukin 6 (pg/ml) [10 days]

   interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

6. Maximal Levels of Interleukin 12 (pg/ml) [10 days]

   interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adults 21-65 years old

• If female of child-bearing potential, willing to use contraception to prevent pregnancy

• Speaks and reads English

• No use of any medication (other than multivitamins, essential fatty acids or probiotics)

• Willing to abstain from ingesting edible mushrooms throughout study

• Willing to eat less than 2 garlic cloves per day throughout study

Exclusion Criteria:

• Positive pregnancy test or currently breastfeeding

• History of autoimmune disease

• History of allergic rhinitis

• History of physician diagnosed eczema

• Known allergic reaction to Echinacea or related species, specifically ragweed (Ambrosia), chamomile (Matricaria), goldenrod (Solidago) and sunflower (Helianthus)

• Use of any medication within 30 days prior to first dose of study medication that is a known inhibitor or inducer of CYP34A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bastyr University	Kenmore	Washington	United States	98028

Sponsors and Collaborators

• University of Washington
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: James A Taylor, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James Taylor, School of Medicine: Pediatrics, University of Washington
• ClinicalTrials.gov Identifier: NCT00860795
• Other Study ID Numbers: 09A1236; 5U01AT002400
• First Posted: Mar 12, 2009
• Last Update Posted: May 1, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by James Taylor, School of Medicine: Pediatrics, University of Washington: Echinacea; prevention; immune modulation
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

Participant Flow

Recruitment Details	Healthy adults were recruited using general advertising and enrolled between March and August 2009

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Period Title: Overall Study
STARTED	10	10
Number to Complete Study Medication	9	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Echinacea	Placebo	Total
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.5 (12.6)	37.4 (14.3)	36.5 (13.2)
Sex: Female, Male (Count of Participants)
Female	8 80%	6 60%	14 70%
Male	2 20%	4 40%	6 30%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
Description	tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [tumor necrosis alpha level (pg/ml)]	2694 (1299)	2648 (1625)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.17
	Comments
	Method	Regression, Linear
	Comments

2. Secondary Outcome

Title	Maximal Levels of Interferon Alpha (pg/ml)
Description	interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [interferon alpha level (pg/ml)]	29 (47)	35 (69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.72
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
Description	NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [(% of NK CD25/69+ cells)]	1.07 (.70)	1.53 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.2
	Comments
	Method	Regression, Linear
	Comments

4. Secondary Outcome

Title	Adverse Effects
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
constipation	1 10%	1 10%
blurred vision	1 10%	1 10%
diarrhea	0 0%	1 10%
gas/indigestion	1 10%	2 20%
nausea	4 40%	1 10%
taste: abnormal/metallic	1 10%	1 10%
musculoskeletal pain	0 0%	1 10%
headache	0 0%	3 30%
fever	1 10%	0 0%
sore throat	0 0%	1 10%
nasal congestion	1 10%	1 10%
rash	1 10%	1 10%
anxiety	1 10%	2 20%
insomnia	0 0%	1 10%
weakness/fatigue	1 10%	1 10%
urinary: difficult/painful	0 0%	1 10%
other	4 40%	2 20%

5. Secondary Outcome

Title	Maximal Levels of Interleukin 2 (pg/ml)
Description	interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [interleukin 2 level (pg/ml)]	287 (244)	829 (1072)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.51
	Comments
	Method	Regression, Linear
	Comments

6. Secondary Outcome

Title	Maximal Levels of Interleukin 6 (pg/ml)
Description	interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [interleukin 6 level (pg/ml)]	5085 (375)	2862 (8761)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.43
	Comments
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Maximal Levels of Interleukin 12 (pg/ml)
Description	interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Echinacea	Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days	25 ml daily in 2 divided doses for 10 days
Measure Participants	10	10
Mean (Standard Deviation) [interleukin 12 level (pg/ml)]	13 (17)	6 (19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Echinacea, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.61
	Comments
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	30 days
Arm/Group Title	Echinacea		Placebo
Arm/Group Description	25 ml daily in 2 divided doses for 10 days		25 ml daily in 2 divided doses for 10 days
All Cause Mortality
	Echinacea		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Echinacea		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Echinacea		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/10 (60%)		7/10 (70%)
Eye disorders
blurred vision	1/10 (10%)		0/10 (0%)
Gastrointestinal disorders
constipation	1/10 (10%)		1/10 (10%)
diarrhea	0/10 (0%)		1/10 (10%)
gas/indigestion	1/10 (10%)		2/10 (20%)
nausea	4/10 (40%)		1/10 (10%)
taste: abnormal/metallic	1/10 (10%)		1/10 (10%)
General disorders
headache	0/10 (0%)		3/10 (30%)
fever	1/10 (10%)		0/10 (0%)
insomnia	0/10 (0%)		1/10 (10%)
weakness/fatigue	1/10 (10%)		1/10 (10%)
other	4/10 (40%)		2/10 (20%)
Musculoskeletal and connective tissue disorders
musculoskeletal pain	0/10 (0%)		1/10 (10%)
Nervous system disorders
anxiety	1/10 (10%)		2/10 (20%)
Renal and urinary disorders
urinary: difficult/painful	0/10 (0%)		1/10 (10%)
Respiratory, thoracic and mediastinal disorders
sore throat	0/10 (0%)		1/10 (10%)
nasal congestion	1/10 (10%)		1/10 (10%)
Skin and subcutaneous tissue disorders
rash	1/10 (10%)		1/10 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.