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Echinacea and Acute Respiratory Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02003651
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 13, 2016
Gaia Herbs Inc.
Information provided by (Responsible Party):
Appalachian State University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
Drug Information available for: Echinacea

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adult women, ages 18 to 55 years.
  • Non-smokers.
  • Willingness to avoid the use of antibiotics, antivirals, nasal steroids, decongestants, antihistamines, combination cold formulas, echinacea, zinc, or vitamin C during the 12-week study.
  • Willingness to maintain normal dietary and physical activity patterns during the 12-week intervention, and not make formal attempts to lose body weight.

Exclusion Criteria:

  • Current history of autoimmune or immune deficiency disease.
  • History of moderate to severe allergic rhinitis with sneezing or itching of the nose or eyes during the winter/early spring.
  • Current history of asthma with coughing, wheezing, or shortness of breath.
  • Pregnant or planning to be pregnant during the study.
  • History of gastrointestinal upsets, rashes, or allergic reactions to Echinacea.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02003651

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United States, North Carolina
ASU-NCRC Human Performance Lab
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Appalachian State University
Gaia Herbs Inc.
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Principal Investigator: David C. Nieman, DrPH Appalachian State University
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Responsible Party: Appalachian State University Identifier: NCT02003651    
Other Study ID Numbers: 14-0064
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: January 2015
Keywords provided by Appalachian State University:
Common cold
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Tract Diseases