Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
Recruitment status was: Recruiting
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.
|Respiratory Infections||Dietary Supplement: Gardemont Goldtrain Plus (GT+)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness|
- Patient Global Assessment (PGA) [ Time Frame: Seven days ]Patient global assessment (PGA) will be a primary measurement, based on the self-reporting answer to the following question: "What is your overall feeling as compared to the first day of treatment: worse, same or better". Time from the enrollment to the first 12 hours when the subject reports on a sustained improvement in symptoms (two consequent 12 hours periods) will be a primary outcome. The study supplement administration will be continued for 7 days.
- Rate of safety composite [ Time Frame: 30 days ]Death, hospitalizations, serious adverse effects
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: Food supplement
Half of the subjects participating in the trial (91) will recieve four tablets of the food supplement (Gardemont Goldrain Plus) three times a day for seven consecutive days from inclusion.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167686
|Contact: Assi Cicurel, MDemail@example.com|
|Contact: Yael Peleg, MAfirstname.lastname@example.org|
|Revivim and Mashabei Sadeh Clalit Clinics||Recruiting|
|Beer Sheba, Israel|
|Contact: Assi Cicurel 972-54-2401500 email@example.com|
|Contact: Yael Peleg, MA 972-8-6479941 firstname.lastname@example.org|
|Principal Investigator: Assi Cicurel, MD|
|Study Director:||Zvi Bentwich, MD||Ben-Gurion University of the Negev|