Clinical trial NCT01167686: Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
Official title: Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Respiratory Infections
Keywords: Respiratory infection
Viral infection
Food supplement
Goldtrain Plus (GT+)
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Clalit Health Services
First posted: 2010-07-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Age eligible (18 ≤ Age ≤ 90)
3. Respiratory infection with or without fever-

Exclusion Criteria:

1. Evidence of the bacterial infection
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 -

Primary outcomes:
measure: Patient Global Assessment (PGA)
timeFrame: Seven days
Secondary outcomes:
measure: Rate of safety composite
timeFrame: 30 days
Other outcomes:
Locations:
city: Beer Sheba
country: Israel
facility: Revivim and Mashabei Sadeh Clalit Clinics
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Zvi Bentwich, MD
role: STUDY_DIRECTOR
References: