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

This study has been completed.
Sponsor:
Information provided by:
Phythea
ClinicalTrials.gov Identifier:
NCT01203670
First received: September 15, 2010
Last updated: September 21, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention
Renal Tolerance
Digestive Tolerance
 Dietary Supplement: Phytalgic

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Phythea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS) [ Time Frame: 168 days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Completion Date: December 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   70 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203670

Locations
France
Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
Phythea
Investigators
Principal Investigator: Alain JACQUET, MD Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux
  More Information

No publications provided

Responsible Party: Pr. Nicholas MOORE, Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre hospitalier universitaire de Bordeaux
ClinicalTrials.gov Identifier: NCT01203670     History of Changes
Other Study ID Numbers: PHYTHEA-e437-950
Study First Received: September 15, 2010
Last Updated: September 21, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Phythea:
Glomerular filtration rate (GFR)
Aspartate Amino Transferase (ASAT)
Alanine Amino transferase (ALAT)
 gamma Glutamyl transpeptidase (gamma GT)
Lipase
Amylase

ClinicalTrials.gov processed this record on June 17, 2013