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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Arantal® (highly bioavailable turmeric extract)
Sponsored by
Bioxtract SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arantal®

Placebo

Arm Description

Highly bioavailable turmeric extract (food supplement)

Same capsule without the active ingredients (only excipients)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2009
Last Updated
May 6, 2010
Sponsor
Bioxtract SA
Collaborators
Nukleus
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1. Study Identification

Unique Protocol Identification Number
NCT00992004
Brief Title
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Official 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).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bioxtract SA
Collaborators
Nukleus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arantal®
Arm Type
Experimental
Arm Description
Highly bioavailable turmeric extract (food supplement)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same capsule without the active ingredients (only excipients)
Intervention Type
Dietary Supplement
Intervention Name(s)
Arantal® (highly bioavailable turmeric extract)
Intervention Description
4 capsules a day, before breakfast
Primary Outcome Measure Information:
Title
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Henrotin, Pr
Organizational Affiliation
University of Liege - Bone and Cartilage Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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