Comparative Study of Turmeric Extract in Patients With Arthrosis.

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.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Arthralgia; Stiffness of Unspecified Joint, Not Elsewhere Classified; Disturbance of Activity and Attention
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Turmeric

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1958 Frb. C
    • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; one capsule daily	Dietary supplement: Placebo; Placebo in gelatin capsules
ACTIVE_COMPARATOR: Turmeric extract; one capsule daily	Dietary supplement: Turmeric; Turmeric in gelatin capsules

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-12 (Quality of life)	Quality of life estimated on a numerical scale (1-3 and 1-6)	3 month
SF-12 (quality of life)	Quality of life estimated on a numerical scale (1-3 and 1-6)	6 month

Collaborators and Investigators

• Sponsor: Kaj Winther Hansen
• Investigators: Principal Investigator: Kaj W Hansen, Prof, DMSCi, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): September 7, 2020
• Study Completion (ACTUAL): September 7, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (ACTUAL): August 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Arthralgia, stiffness of joints, quality of life
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia
• Other Study ID Numbers: Tr-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No