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

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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Infections
• Intervention / Treatment: Dietary supplement: Gardemont Goldtrain Plus (GT+)

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Beer Sheba, Israel
    • Recruiting
    • Revivim and Mashabei Sadeh Clalit Clinics
    • Contact: Yael Peleg, MA; Phone Number: 972-8-6479941; Email: ypeleg@bgu.ac.il
    • Contact: Assi Cicurel; Phone Number: 972-54-2401500; Email: cicurels@gmail.com
    • Principal Investigator: Assi Cicurel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: Ben-Gurion University of the Negev; Clalit Health Services
• Investigators: Study Director: Zvi Bentwich, MD, Ben-Gurion University of the Negev

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 16, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Food supplement; Respiratory infection; Viral infection; Goldtrain Plus (GT+)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: k008/2010