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OpenTrials
Completed

NCT Number: NCT01203670

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

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

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Key information

Conditions

Renal Tolerance Digestive Tolerance

Age range

70 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux

Bordeaux, 33076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • ASAT : Men < 150 UI/L - Women < 100 UI/L
  • ALAT : Men < 180 UI/l - Women < 130 UI:l
  • Gamma GT Men < 180 UI/l - Gamma GT Women < 100 UI/l
  • Amylase < 250 UI/l
  • 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

Treatment and study plan

Phytalgic

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)

    Time frame: 168 days

Sponsors and collaborators

Lead sponsor

Phythea

Industry

Registry information

Important dates

Study completion
2009
First posted
Sep 16, 2010
Registry last updated
Sep 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.