Respiratory Infections Clinical Trial
Official title:
Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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