Comparative Study of Turmeric Extract in Patients With Arthrosis.

Study Overview
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Brief Summary
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The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.

Detailed Description
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The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary. The treatment period is 3 month with the posibility to continue for an additional 3 month.

Official Title
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A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.

Conditions
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Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Turmeric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers 40 years of age or more Osteoarthritis of the hip and or the knee Suffering from pain in the hip and or knee - Exclusion Criteria: If volunteers are on a waiting list for hip or knee surgery If the volunteers are involved in an other clinical trial If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis. Abusers of alcohol and drugs Volunteers not easy to cope with

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>one capsule daily | Dietary Supplement: Placebo<br>* Placebo in gelatin capsules<br>|
| Active Comparator: Turmeric extract<br>one capsule daily | Dietary Supplement: Turmeric<br>* Turmeric in gelatin capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Difference in WOMAC pain on a 100 mm VAS scale (high levels worse) | 3 month | 
| Pain | Difference in WOMAC pain on a 100 mm VAS scale (high levels worse) | 6 month | 
| ADL (Activity of daily living) | Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse) | 3 month | 
| ADL (Activity of daily living) | Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse) | 6 month | 
| Rescue medication | Consumption of rescue medication from diaries (mg) | 3 month | 
| Rescue medication | Consumption of rescue medication from diaries (mg) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stiffness of joints | Difference in stiffness of joints on a 100 mm VAS scale (higher values worse) | 3 month | 
| Stiffness of joints | Difference in stiffness of joints on a 100 mm VAS scale (higher values worse) | 6 month | 
| The volunteer evaluation of Global Disease Severity (PGAD) | PGAD is measured on a 100 mm VAS scale (higher values worse) | 3 month | 
| The volunteer evaluation of Global Disease Severity (PGAD) | PGAD is measured on a 100 mm VAS scale (higher values worse) | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthralgia, stiffness of joints, quality of life