Status:
COMPLETED
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
Lead Sponsor:
Phythea
Conditions:
Renal Tolerance
Digestive Tolerance
Eligibility:
All Genders
70-87 years
Phase:
NA
Brief Summary
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.
Eligibility Criteria
Inclusion
- 70 years old minimum
- Satisfying general health judged by principal investigator
- Pain and /or stifness associated with arthritis
- Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs)
- Digestive tolerance biomarkers
- ASAT : Men \< 150 UI/L - Women \< 100 UI/L
- ALAT : Men \< 180 UI/l - Women \< 130 UI:l
- Gamma GT Men \< 180 UI/l - Gamma GT Women \< 100 UI/l
- Amylase \< 250 UI/l
- Lipase \< 750 UI/l
- Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the "Modification of the Diet in Renal Diseases" formula
Exclusion
- Inflammatory arthritis
- Allergy to any constituents of the study drug
- Types 2 diabetes
- Not legally fit to participate
- Any treatment able to modify determined biological parameters
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01203670
End Date
December 1 2009
Last Update
September 22 2010
Active Locations (1)
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1
Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux
Bordeaux, France, 33076