Echinacea and Acute Respiratory Illness

NCT02003651 | Completed

• 1 other identifier: 14-0064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Infections

Keywords

Common cold

Outcome Measures

Primary Outcomes (1)

• Common cold symptoms

  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.

  12-weeks

Study Arms (2)

Quick Defense

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Quick Defense DIETARY_SUPPLEMENT

Echinacea product from Gaia Herbs.

Quick Defense

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Appalachian State University: lead
• Gaia Herbs Inc.: collaborator

Study Sites (1)

ASU-NCRC Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David C. Nieman, DrPH

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 13, 2016

Record last verified: 2015-01

Locations

US (1)