NCT00240461

Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial

Completed Phase 3 Last updated 6 July 2011

What this trial tests

Phase 3 trial testing COLD-fX natural health product in Respiratory Tract Infection in 780 participants. Completed in 1 December 2008.

Timeline

1 September 2005

Primary endpoint
1 May 2008

1 December 2008

Quick facts

Lead sponsor	Capital Health, Canada
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	prevention
Enrollment	780
Start date	1 September 2005
Primary completion	1 May 2008
Estimated completion	1 December 2008
Sites	5 locations across Canada, Netherlands

Drugs / interventions tested

• COLD-fX natural health product
• COLD-fX — full drug profile →
• Placebo

Conditions studied

• Respiratory Tract Infection — all drugs for Respiratory Tract Infection →

Sponsor

Capital Health, Canada

Who can join

65 and older, any sex, with Respiratory Tract Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
  Time frame: During the study time frame of 6 months

Sponsor's own description

Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Review of Ginseng Clinical Trials Registered in the WHO International Clinical Trials Registry Platform.
   He Y, Yang J, Lv Y, Chen J, et al · · 2018 · cited 24× · PMID 29546050 · DOI 10.1155/2018/1843142
2. Efficacy and Safety of CVT-E002, a Proprietary Extract of Panax quinquefolius in the Prevention of Respiratory Infections in Influenza-Vaccinated Community-Dwelling Adults: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Trial.
   McElhaney JE, Simor AE, McNeil S, Predy GN. · · 2011 · cited 10× · PMID 23074661 · DOI 10.1155/2011/759051