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

NCT01167686 | Unknown Phase 2 DMC

• 1 other identifier: k008/2010
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infections

Keywords

Respiratory infection; Viral infection; Food supplement; Goldtrain Plus (GT+)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of safety composite

  30 days

Study Arms (1)

Food supplement

EXPERIMENTAL

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+)

Interventions

Gardemont Goldtrain Plus (GT+) DIETARY_SUPPLEMENT

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

Food supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Age eligible (18 ≤ Age ≤ 90)
• Respiratory infection with or without fever-

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Meir Medical Center: lead
• Ben-Gurion University of the Negev: collaborator
• Clalit Health Services: collaborator

Study Sites (1)

Revivim and Mashabei Sadeh Clalit Clinics

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Zvi Bentwich, MD

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

Central Study Contacts

Assi Cicurel, MD

CONTACT

972-54-2401500; cicurels@gmail.com

Yael Peleg, MA

CONTACT

972-8-6479941; ypeleg@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 22, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2012
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

IL (1)