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| Name | Class |
|---|---|
| Ben-Gurion University of the Negev | OTHER |
| Clalit Health Services | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of safety composite | Death, hospitalizations, serious adverse effects | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assi Cicurel, MD | Contact | 972-54-2401500 | cicurels@gmail.com | |
| Yael Peleg, MA | Contact | 972-8-6479941 | ypeleg@bgu.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Zvi Bentwich, MD | Ben-Gurion University of the Negev | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Revivim and Mashabei Sadeh Clalit Clinics | Recruiting | Beersheba | Israel |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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