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

Phythea

Status: Completed

Conditions: Renal Tolerance; Digestive Tolerance

Treatments: Dietary Supplement: Phytalgic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203670

PHYTHEA-e437-950

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 70 to 87 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Soft capsules of Phytalgic

Experimental group

Description:

Phytalgic is a food supplement. Its galenic form is soft capsule.

Treatment:

Dietary Supplement: Phytalgic