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Trial record 5 of 27 for:    Echinacea

Immunologic Effects of Echinacea

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ClinicalTrials.gov Identifier: NCT00860795
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : November 17, 2010
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
James Taylor, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Upper Respiratory Tract Infections
Interventions Biological: Echinacea purpurea
Drug: placebo
Enrollment 20
Recruitment Details Healthy adults were recruited using general advertising and enrolled between March and August 2009
Pre-assignment Details  
Arm/Group Title Echinacea Placebo
Hide 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 [1] 10
Not Completed 0 0
[1]
One participant discontinued study medication on day 5, but completed safety evaluations
Arm/Group Title Echinacea Placebo Total
Hide 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 Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
35.5  (12.6) 37.4  (14.3) 36.5  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
6
  60.0%
14
  70.0%
Male
2
  20.0%
4
  40.0%
6
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)
Hide Description tumor necrosis factor alpha NK cells and evidence of CD25/69 activation
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: tumor necrosis alpha level (pg/ml)
2694  (1299) 2648  (1625)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .17
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Maximal Levels of Interferon Alpha (pg/ml)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: interferon alpha level (pg/ml)
29  (47) 35  (69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .72
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Maximal CD25/69 Activation (% of NK CD25/69+ Cells)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: (% of NK CD25/69+ cells)
1.07  (.70) 1.53  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .2
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title Adverse Effects
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
constipation 1 1
blurred vision 1 1
diarrhea 0 1
gas/indigestion 1 2
nausea 4 1
taste: abnormal/metallic 1 1
musculoskeletal pain 0 1
headache 0 3
fever 1 0
sore throat 0 1
nasal congestion 1 1
rash 1 1
anxiety 1 2
insomnia 0 1
weakness/fatigue 1 1
urinary: difficult/painful 0 1
other 4 2
5.Secondary Outcome
Title Maximal Levels of Interleukin 2 (pg/ml)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: interleukin 2 level (pg/ml)
287  (244) 829  (1072)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .51
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
6.Secondary Outcome
Title Maximal Levels of Interleukin 6 (pg/ml)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: interleukin 6 level (pg/ml)
5085  (375) 2862  (8761)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .43
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
7.Secondary Outcome
Title Maximal Levels of Interleukin 12 (pg/ml)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Echinacea Placebo
Hide Arm/Group Description:
25 ml daily in 2 divided doses for 10 days
25 ml daily in 2 divided doses for 10 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: interleukin 12 level (pg/ml)
13  (17) 6  (19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Echinacea, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .61
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Echinacea Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Echinacea Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Echinacea Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   7/10 (70.00%) 
Eye disorders     
blurred vision  1  1/10 (10.00%)  0/10 (0.00%) 
Gastrointestinal disorders     
constipation  1  1/10 (10.00%)  1/10 (10.00%) 
diarrhea  1  0/10 (0.00%)  1/10 (10.00%) 
gas/indigestion  1  1/10 (10.00%)  2/10 (20.00%) 
nausea  1  4/10 (40.00%)  1/10 (10.00%) 
taste: abnormal/metallic  1  1/10 (10.00%)  1/10 (10.00%) 
General disorders     
headache  1  0/10 (0.00%)  3/10 (30.00%) 
fever  1  1/10 (10.00%)  0/10 (0.00%) 
insomnia  1  0/10 (0.00%)  1/10 (10.00%) 
weakness/fatigue  1  1/10 (10.00%)  1/10 (10.00%) 
other  1 [1]  4/10 (40.00%)  2/10 (20.00%) 
Musculoskeletal and connective tissue disorders     
musculoskeletal pain  1  0/10 (0.00%)  1/10 (10.00%) 
Nervous system disorders     
anxiety  1  1/10 (10.00%)  2/10 (20.00%) 
Renal and urinary disorders     
urinary: difficult/painful  1  0/10 (0.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
sore throat  1  0/10 (0.00%)  1/10 (10.00%) 
nasal congestion  1  1/10 (10.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
rash  1  1/10 (10.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MOSES
[1]
tongue tingling, tongue numbness, lip numbness reported by 3 participants taking Echinacea
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.
Results Point of Contact
Name/Title: James A Taylor, MD
Organization: University of Washington
Phone: 206-616-1206
Responsible Party: James Taylor, University of Washington
ClinicalTrials.gov Identifier: NCT00860795     History of Changes
Other Study ID Numbers: 09A1236
5U01AT002400 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2009
First Posted: March 12, 2009
Results First Submitted: September 28, 2010
Results First Posted: November 17, 2010
Last Update Posted: May 1, 2018