Skip to main content
OpenTrials
Completed

NCT Number: NCT00992004

Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).

The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henri Mondor Hospital

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is 40 through 80 years of age
  • Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
  • Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
  • Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
  • Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
  • Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
  • Patients having signed the informed consent,
  • Patients capable of comprehend the study instructions.

Exclusion criteria

  • Related to the osteoarthritis pathology:
  • Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
  • Predominant associated symptomatic femoropatellar osteoarthritis,
  • Chondromatosis or villonodular synovitis of the knee,
  • Recent trauma (< 1 month) of the knee responsible for the pain,
  • Knee joint effusion justifying an evacuation through puncturing,
  • Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
  • Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
  • Related to previous and associated treatments:
  • Corticosteroids injection in the previous month, whatever the joint concerned,
  • Hyaluronan injection in the evaluated knee during the previous 6 months,
  • Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
  • Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
  • Anticoagulant treatment without gastric protection,
  • General corticotherapy,
  • Contraindication to paracetamol.
  • Related to associated pathologies:
  • Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  • Peptic ulcer.
  • Related to patients:
  • Pregnant or breastfeeding women
  • Pre-menopausal women with no contraception
  • Patients unable to write
  • Patients enrolled in a clinical trial in the previous 3 months
  • Patients under juristic protection or under guardianship.

Treatment and study plan

Arantal® (highly bioavailable turmeric extract)

Dietary Supplement

4 capsules a day, before breakfast

Primary outcomes

  1. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    Time frame: 15 days

Secondary outcomes

  1. Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Bioxtract SA

Industry

Collaborators

  • Nukleus

Registry information

Official study title

Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2009
Registry last updated
May 7, 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.

Published trials that share one or more normalized conditions with this study.