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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 15, 2014