Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
NCT ID: NCT01203670
Last Updated: 2010-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Soft capsules of Phytalgic
Phytalgic is a food supplement. Its galenic form is soft capsule.
Phytalgic
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
Interventions
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Phytalgic
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
Eligibility Criteria
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Inclusion Criteria
* 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
1. ASAT : Men \< 150 UI/L - Women \< 100 UI/L
2. ALAT : Men \< 180 UI/l - Women \< 130 UI:l
3. Gamma GT Men \< 180 UI/l - Gamma GT Women \< 100 UI/l
4. Amylase \< 250 UI/l
5. 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 Criteria
* Allergy to any constituents of the study drug
* Types 2 diabetes
* Not legally fit to participate
* Any treatment able to modify determined biological parameters
70 Years
87 Years
ALL
No
Sponsors
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Phythea
INDUSTRY
Responsible Party
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Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre hospitalier universitaire de Bordeaux
Principal Investigators
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Alain JACQUET, MD
Role: PRINCIPAL_INVESTIGATOR
Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux
Locations
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Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux
Bordeaux, , France
Countries
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Other Identifiers
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PHYTHEA-e437-950
Identifier Type: -
Identifier Source: org_study_id