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

Digestive Tolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203670
• Other study ID #: PHYTHEA-e437-950
• Status: Completed
• Phase: N/A
• First received: September 15, 2010
• Last updated: September 21, 2010
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: Phythea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 87 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Digestive Tolerance
• Renal Tolerance

Intervention

Dietary Supplement:
• Phytalgic
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.

Locations

Country	Name	City	State
France	Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Phythea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)		168 days	Yes