Comparative Study of Turmeric Extract in Patients With Arthrosis.

Quality of Life Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500210
• Other study ID #: Tr-01
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: September 7, 2020

Study information

• Verified date: July 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 7, 2020
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Placebo
Placebo in gelatin capsules
• Turmeric
Turmeric in gelatin capsules

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Kaj Winther Hansen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SF-12 (Quality of life)	Quality of life estimated on a numerical scale (1-3 and 1-6)	3 month
Other	SF-12 (quality of life)	Quality of life estimated on a numerical scale (1-3 and 1-6)	6 month
Primary	Pain	Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)	3 month
Primary	Pain	Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)	6 month
Primary	ADL (Activity of daily living)	Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)	3 month
Primary	ADL (Activity of daily living)	Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)	6 month
Primary	Rescue medication	Consumption of rescue medication from diaries (mg)	3 month
Primary	Rescue medication	Consumption of rescue medication from diaries (mg)	6 month
Secondary	Stiffness of joints	Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)	3 month
Secondary	Stiffness of joints	Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)	6 month
Secondary	The volunteer evaluation of Global Disease Severity (PGAD)	PGAD is measured on a 100 mm VAS scale (higher values worse)	3 month
Secondary	The volunteer evaluation of Global Disease Severity (PGAD)	PGAD is measured on a 100 mm VAS scale (higher values worse)	6 month