Echinacea and Acute Respiratory Illness
|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|
|Acute Respiratory Infections||Dietary Supplement: Quick Defense Dietary Supplement: Placebo|
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|
|Primary Completion Date :||April 2014|
|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.
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|