Status:
UNKNOWN
Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
Lead Sponsor:
Meir Medical Center
Collaborating Sponsors:
Ben-Gurion University of the Negev
Clalit Health Services
Conditions:
Respiratory Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 infe...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Exclusion
- 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 -
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01167686
Start Date
March 1 2010
End Date
December 1 2012
Last Update
March 19 2012
Active Locations (1)
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1
Revivim and Mashabei Sadeh Clalit Clinics
Beersheba, Israel