NCT01167686

Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness

Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection. Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms. Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication. Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.

Conditions

• Respiratory Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gardemont Goldtrain Plus (GT+)	Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-11-01
• Completion: 2012-12-01
• First posted: 2010-07-22
• Last updated: 2012-03-19

Locations

1 site across 1 country: Israel