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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Beer Sheba, Israël
- Recrutement
- Revivim and Mashabei Sadeh Clalit Clinics
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Contact:
- Yael Peleg, MA
- Numéro de téléphone: 972-8-6479941
- E-mail: ypeleg@bgu.ac.il
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Contact:
- Assi Cicurel
- Numéro de téléphone: 972-54-2401500
- E-mail: cicurels@gmail.com
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Chercheur principal:
- Assi Cicurel, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Exclusion Criteria:
- 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 -
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Global Assessment (PGA)
Délai: Seven days
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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.
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Seven days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Rate of safety composite
Délai: 30 days
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Death, hospitalizations, serious adverse effects
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30 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Zvi Bentwich, MD, Ben-Gurion University of the Negev
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- k008/2010
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