Comparative Study of Turmeric Extract in Patients With Arthrosis.

Phase 3

Completed

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

• Registration Number: NCT04500210
• Lead Sponsor: Kaj Winther Hansen

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-03
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ADL (Activity of daily living)	6 month	Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Pain	6 month	Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Rescue medication	6 month	Consumption of rescue medication from diaries (mg)

Secondary Outcome Measures

Name	Time	Method
Stiffness of joints	6 month	Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
The volunteer evaluation of Global Disease Severity (PGAD)	6 month	PGAD is measured on a 100 mm VAS scale (higher values worse)

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Denmark