Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
This study has been completed.
Information provided by:
First received: September 15, 2010
Last updated: September 21, 2010
Last verified: September 2010
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial|
Resource links provided by NLM:
Further study details as provided by Phythea:
Primary Outcome Measures:
- Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination [ Time Frame: 168 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS) [ Time Frame: 168 days ] [ Designated as safety issue: Yes ]
|Study Completion Date:||December 2009|
Experimental: Soft capsules of Phytalgic
Phytalgic is a food supplement. Its galenic form is soft capsule.
Dietary Supplement: Phytalgic
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203670
|Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux|
|Bordeaux, France, 33076|
Sponsors and Collaborators
|Principal Investigator:||Alain JACQUET, MD||Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux|