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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ben Gurion Universiy of the Negev
Clalit Health Services
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01167686
First received: July 21, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Respiratory Infections
Dietary Supplement: Gardemont Goldtrain Plus (GT+)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Patient Global Assessment (PGA) [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Rate of safety composite [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Death, hospitalizations, serious adverse effects


Estimated Enrollment: 182
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167686

Contacts
Contact: Assi Cicurel, MD 972-54-2401500 cicurels@gmail.com
Contact: Yael Peleg, MA 972-8-6479941 ypeleg@bgu.ac.il

Locations
Israel
Revivim and Mashabei Sadeh Clalit Clinics Recruiting
Beer Sheba, Israel
Contact: Assi Cicurel    972-54-2401500    cicurels@gmail.com   
Contact: Yael Peleg, MA    972-8-6479941    ypeleg@bgu.ac.il   
Principal Investigator: Assi Cicurel, MD         
Sponsors and Collaborators
Meir Medical Center
Ben Gurion Universiy of the Negev
Clalit Health Services
Investigators
Study Director: Zvi Bentwich, MD Ben-Gurion University of the Negev
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01167686     History of Changes
Other Study ID Numbers: k008/2010
Study First Received: July 21, 2010
Last Updated: March 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Respiratory infection
Viral infection
Food supplement
Goldtrain Plus (GT+)

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014