Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

Not Applicable

Completed

• Conditions: Renal Tolerance; Digestive Tolerance
• Interventions: Dietary Supplement: Phytalgic

• Registration Number: NCT01203670
• Lead Sponsor: Phythea

Brief Summary

The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.

Detailed Description

Not available

Study Timeline

• Study Completion: 2009-12
• Status Verified: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Last Update Submitted: 2010-09-21
• Last Update Posted: 2010-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

  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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soft capsules of Phytalgic	Phytalgic	Phytalgic is a food supplement. Its galenic form is soft capsule.

Primary Outcome Measures

Name	Time	Method
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	168 days

Secondary Outcome Measures

Name	Time	Method
Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)	168 days

Trial Locations

Locations (1)

Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux; 🇫🇷 Bordeaux, France