Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
NCT ID: NCT01167686
Last Updated: 2012-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
182 participants
INTERVENTIONAL
2010-03-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age eligible (18 ≤ Age ≤ 90)
3. Respiratory infection with or without fever-
Exclusion Criteria
2. Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
3. Hospitalisation is planned
4. Surgery within previous 2 months
5. Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
6. Subject with known renal dysfunction (creatinine ≥ 2 mg/dL)
7. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN
8. Participation in the active follow-up phase of another clinical study of an investigational drug or device
9. Known hypercalcemia -
18 Years
80 Years
ALL
No
Sponsors
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Ben-Gurion University of the Negev
OTHER
Clalit Health Services
OTHER
Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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Zvi Bentwich, MD
Role: STUDY_DIRECTOR
Ben-Gurion University of the Negev
Locations
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Revivim and Mashabei Sadeh Clalit Clinics
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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k008/2010
Identifier Type: -
Identifier Source: org_study_id
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