Echinacea and Acute Respiratory Illness
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|ClinicalTrials.gov Identifier: NCT02003651|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 13, 2016
The primary objective of this study is to evaluate the effectiveness of ingesting an alkylamide-rich echinacea root product (Quick Defense, Gaia Herbs) for 2 days immediately following each onset of acute respiratory illness (ARI) symptomatology during a 12-week period in the winter and early spring in women.
Hypothesis: Subjects randomized to Quick Defense compared to placebo over a 12-week period will experience reduced ARI symptomatology, both acutely during each ARI episode and collectively over the entire 12-week study period.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Infections||Dietary Supplement: Quick Defense Dietary Supplement: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Ingesting Gaia Herb's Quick Defense Product in Reducing Acute Respiratory Illness Symptomatology in Women: a 12-Week, Double Blind, Placebo-Controlled Randomized Trial|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Quick Defense
250 mg E. purpurea root and 83 mg E.angustifolia root standardized to 10 mg alkylamides, and 210 mg of a proprietary synergistic extract blend containing andrographis paniculata leaf, black elderberry berries, sambucus nigra, ginger root, and zingiber officinale
Dietary Supplement: Quick Defense
Echinacea product from Gaia Herbs.
Placebo Comparator: Placebo
Placebo will contain the excipients vegetable glycerin and olive oil. Placebo and echinacea capsules will be colored green and contain the same proportions of inert ingredients.
Dietary Supplement: Placebo
- Common cold symptoms [ Time Frame: 12-weeks ]The Wisconsin Upper Respiratory Symptom Survey (WURSS-24) will be used to assess common cold illness severity and symptoms (see attached questionnaire). Subjects will fill in the one-page WURSS-24 at the end of each day during the 12-week monitoring period. This 12-week period will cover the winter and early spring period of 2014. From the responses recorded during the 84-day study, an ARI severity score will be calculated by summing the daily ARI global severity score (0=not sick, 1=very mild ARI to 7=severe). The ARI symptom score for the 84-day period will be calculated by summing all 10 symptom scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). In similar fashion, the ARI function ability score for the 84-day period will be calculated by summing all 9 function scores for each day's entry (0=do not have this symptom, 1=very mild to 7=severe). Separate scores will be calculated comparing groups for each illness episode recorded by the subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003651
|United States, North Carolina|
|ASU-NCRC Human Performance Lab|
|Kannapolis, North Carolina, United States, 28081|
|Principal Investigator:||David C. Nieman, DrPH||Appalachian State University|