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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01203670

Enrollment

Registered

2010-09-16

Start date

Unknown

Completion date

2009-12-31

Last updated

2010-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Tolerance, Renal Tolerance

Keywords

Glomerular filtration rate (GFR), Aspartate Amino Transferase (ASAT), Alanine Amino transferase (ALAT), gamma Glutamyl transpeptidase (gamma GT), Lipase, Amylase

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPhytalgic

Volunteers have to take three soft capsules per day, one in the morning and two in the evening.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to 87 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026