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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Infections

Intervention / Treatment
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* Dietary Supplement: Gardemont Goldtrain Plus (GT+)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Age eligible (18 ≤ Age ≤ 90) Respiratory infection with or without fever- Exclusion Criteria: Evidence of the bacterial infection Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms). Hospitalisation is planned Surgery within previous 2 months Pregnancy (women at childbirth age should have a urine beta-HCG test performed) Subject with known renal dysfunction (creatinine ≥ 2 mg/dL) Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN Participation in the active follow-up phase of another clinical study of an investigational drug or device Known hypercalcemia -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food supplement<br>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+)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment (PGA) | 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. | Seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of safety composite | Death, hospitalizations, serious adverse effects | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory infection, Viral infection, Food supplement, Goldtrain Plus (GT+)