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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- ADL (Activity of daily living)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
one capsule daily
Intervention: Placebo (Dietary Supplement)
Turmeric extract
one capsule daily
Intervention: Turmeric (Dietary Supplement)
Outcomes
Primary Outcomes
ADL (Activity of daily living)
Time Frame: 6 month
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Pain
Time Frame: 6 month
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Rescue medication
Time Frame: 6 month
Consumption of rescue medication from diaries (mg)
Pain
Time Frame: 3 month
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
ADL (Activity of daily living)
Time Frame: 3 month
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Rescue medication
Time Frame: 3 month
Consumption of rescue medication from diaries (mg)
Secondary Outcomes
- Stiffness of joints(6 month)
- The volunteer evaluation of Global Disease Severity (PGAD)(6 month)
- Stiffness of joints(3 month)
- The volunteer evaluation of Global Disease Severity (PGAD)(3 month)
Investigators
Kaj Winther Hansen
professor, MD, DMsCi
University of Copenhagen