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

Respiratory Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01167686
• Other study ID #: k008/2010
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: March 16, 2012
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Assi Cicurel, MD
• Phone: 972-54-2401500
• Email: cicurels[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Infections
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Israel	Revivim and Mashabei Sadeh Clalit Clinics	Beer Sheba

Sponsors (3)

Lead Sponsor	Collaborator
Meir Medical Center	Ben-Gurion University of the Negev, Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rate of safety composite	Death, hospitalizations, serious adverse effects	30 days	Yes