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

September 21, 2010 updated by: Phythea
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 87 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soft capsules of Phytalgic
Phytalgic is a food supplement. Its galenic form is soft capsule.
Dietary supplement: Phytalgic
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 168 days
168 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phythea

Investigators

  • Principal Investigator: Alain JACQUET, MD, Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHYTHEA-e437-950

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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