Echinacea and Acute Respiratory Illness

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Appalachian State University
Sponsor:
Collaborator:
Gaia Herbs
Information provided by (Responsible Party):
Appalachian State University
ClinicalTrials.gov Identifier:
NCT02003651
First received: December 2, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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 Intervention
Acute Respiratory Infections
Dietary Supplement: Quick Defense

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Appalachian State University:

Primary Outcome Measures:
  • Common cold symptoms [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003651

Contacts
Contact: David C. Nieman, DrPH 704-250-5351 niemandc@appstate.edu
Contact: Dustin Dew, MS 704-250-5351 dustindew@gmail.com

Locations
United States, North Carolina
ASU-NCRC Human Performance Lab Recruiting
Kannapolis, North Carolina, United States, 28081
Contact: Dustin Dew, MS    704-250-5351    dustindew@gmail.com   
Principal Investigator: David C. Nieman, DrPH         
Sponsors and Collaborators
Appalachian State University
Gaia Herbs
Investigators
Principal Investigator: David C. Nieman, DrPH Appalachian State University
  More Information

No publications provided

Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT02003651     History of Changes
Other Study ID Numbers: 14-0064
Study First Received: December 2, 2013
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Appalachian State University:
Common cold

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014