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Trial record 7 of 28 for:    Echinacea

Three Arm Trial of Immune Effects of Echinacea

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ClinicalTrials.gov Identifier: NCT01129128
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : June 5, 2012
Last Update Posted : June 21, 2012
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: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Upper Respiratory Tract Infections
Interventions Biological: Echinacea purpurea product
Biological: Placebo
Enrollment 67
Recruitment Details Healthy adult volunteers enrolled from May 2010 through March 2011
Pre-assignment Details  
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description Echinacea purpurea product; 5 ml dose administered three times daily for 10 days Echinacea purpurea product; 1 ml dose administered three times daily for 10 days Inert liquid that is similar in appearance and taste to the active Echinacea products
Period Title: Overall Study
Started 22 22 23
Completed 19 18 19
Not Completed 3 4 4
Reason Not Completed
Lost to Follow-up             2             2             1
Protocol Violation             0             1             0
Withdrawal by Subject             0             1             3
Physician Decision             1             0             0
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo Total
Hide Arm/Group Description Echinacea purpurea product; 5 ml dose administered three times daily for 10 days Echinacea purpurea product; 1 ml dose administered three times daily for 10 days Inert liquid that is similar in appearance and taste to the active Echinacea products Total of all reporting groups
Overall Number of Baseline Participants 22 22 23 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 23 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
23
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 23 participants 67 participants
34.1  (10.6) 35.1  (13.5) 28.2  (8.0) 32.4  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 23 participants 67 participants
Female
16
  72.7%
14
  63.6%
17
  73.9%
47
  70.1%
Male
6
  27.3%
8
  36.4%
6
  26.1%
20
  29.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 23 participants 67 participants
22 22 23 67
1.Primary Outcome
Title Peak Level of TNF Alpha
Hide Description Highest level of TNF alpha while taking study medication
Time Frame 1-10 days after starting study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description:
Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: pg/ml
436  (510) 1467  (2330) 721  (1272)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #1 (5 ml/Dose), Placebo
Comments comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -173
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #2 (1 ml/Dose), Placebo
Comments comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 705
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Peak Level IL-6
Hide Description Highest level of IL-6 while taking study medication
Time Frame 1-10 days after starting study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description:
Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: pg/ml
16296  (37448) 44901  (79868) 28526  (61921)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #1 (5 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15793
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #2 (1 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23472
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Peak Level Interferon Gamma
Hide Description Highest level of Interferon gamma while taking study medication
Time Frame 1-10 days after starting study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description:
Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: pg/ml
74  (122) 146  (321) 121  (292)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #1 (5 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #2 (1 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Peak Level IL-2
Hide Description Highest level of IL-2 while taking study medication
Time Frame 1-10 days after starting study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description:
Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Deviation)
Unit of Measure: pg/ml
82  (79) 148  (321) 68  (64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #1 (5 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Commercially Available Echinacea Product #2 (1 ml/Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Regression, Linear
Comments controlled for baseline levels
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 39
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared
Time Frame 1- 30 days after starting study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study medication
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description:
Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
Inert liquid that is similar in appearance and taste to the active Echinacea products
Overall Number of Participants Analyzed 22 22 22
Measure Type: Number
Unit of Measure: participants
14 18 16
Time Frame day 1 (first dose of study medication) through day 30
Adverse Event Reporting Description Patients specifically inquired about adverse events on day 2, 3, 7, 10, 17 and 30 using 76-item questionnaire.
 
Arm/Group Title Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Hide Arm/Group Description Echinacea purpurea product; 5 ml dose administered three times daily for 10 days Echinacea purpurea product; 1 ml dose administered three times daily for 10 days Inert liquid that is similar in appearance and taste to the active Echinacea products
All-Cause Mortality
Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Commercially Available Echinacea Product #1 (5 ml/Dose) Commercially Available Echinacea Product #2 (1 ml/Dose) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/22 (63.64%)   18/22 (81.82%)   16/22 (72.73%) 
Gastrointestinal disorders       
Abdominal pain/cramps  1  4/22 (18.18%)  3/22 (13.64%)  1/22 (4.55%) 
Appetite: decreased  1  3/22 (13.64%)  1/22 (4.55%)  3/22 (13.64%) 
Appetite: increased  1  4/22 (18.18%)  0/22 (0.00%)  1/22 (4.55%) 
constipation  1  3/22 (13.64%)  1/22 (4.55%)  1/22 (4.55%) 
Diarrhea  1  2/22 (9.09%)  0/22 (0.00%)  3/22 (13.64%) 
Dry mouth  1  1/22 (4.55%)  3/22 (13.64%)  1/22 (4.55%) 
Gas/indigestion  1  6/22 (27.27%)  3/22 (13.64%)  2/22 (9.09%) 
Nausea  1  4/22 (18.18%)  2/22 (9.09%)  2/22 (9.09%) 
General disorders       
Drowsiness/sedation  1  3/22 (13.64%)  3/22 (13.64%)  1/22 (4.55%) 
Sleep: excessive  1  1/22 (4.55%)  3/22 (13.64%)  2/22 (9.09%) 
Sleep: insomnia, restless  1  3/22 (13.64%)  4/22 (18.18%)  3/22 (13.64%) 
Weakness/fatigue  1  5/22 (22.73%)  4/22 (18.18%)  3/22 (13.64%) 
Metabolism and nutrition disorders       
Thirst: increased  1  4/22 (18.18%)  1/22 (4.55%)  2/22 (9.09%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  2/22 (9.09%)  2/22 (9.09%)  0/22 (0.00%) 
Nervous system disorders       
Headache  1  4/22 (18.18%)  5/22 (22.73%)  6/22 (27.27%) 
Psychiatric disorders       
Anxiety  1  3/22 (13.64%)  1/22 (4.55%)  2/22 (9.09%) 
Depression  1  1/22 (4.55%)  1/22 (4.55%)  2/22 (9.09%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion  1  5/22 (22.73%)  7/22 (31.82%)  8/22 (36.36%) 
Sore throat  1  2/22 (9.09%)  5/22 (22.73%)  4/22 (18.18%) 
Skin and subcutaneous tissue disorders       
Rash/hives  1  3/22 (13.64%)  0/22 (0.00%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MOSES
Levels of TNF alpha, IL-6, IL-2 and Interferon gamma varied widely limiting chance of detecting differences.
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
Layout table for Results Point of Contact information
Name/Title: James A Taylor, MD
Organization: University of Washington
Phone: 206-616-1206
EMail: uncjat@uw.edu
Layout table for additonal information
Responsible Party: James Taylor, University of Washington
ClinicalTrials.gov Identifier: NCT01129128     History of Changes
Other Study ID Numbers: 10A1276
First Submitted: May 14, 2010
First Posted: May 24, 2010
Results First Submitted: May 4, 2012
Results First Posted: June 5, 2012
Last Update Posted: June 21, 2012