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Comparative Study of Turmeric Extract in Patients With Arthrosis.

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Turmeric
Sponsored by
Kaj Winther Hansen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthralgia focused on measuring Arthralgia, stiffness of joints, quality of life

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Turmeric extract

Arm Description

one capsule daily

one capsule daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2020
Last Updated
October 22, 2021
Sponsor
Kaj Winther Hansen
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1. Study Identification

Unique Protocol Identification Number
NCT04500210
Brief Title
Comparative Study of Turmeric Extract in Patients With Arthrosis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 7, 2020 (Actual)
Study Completion Date
September 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kaj Winther Hansen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Stiffness of Unspecified Joint, Not Elsewhere Classified, Disturbance of Activity and Attention, Quality of Life
Keywords
Arthralgia, stiffness of joints, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one capsule daily
Arm Title
Turmeric extract
Arm Type
Active Comparator
Arm Description
one capsule daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo in gelatin capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Intervention Description
Turmeric in gelatin capsules
Primary Outcome Measure Information:
Title
Pain
Description
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Time Frame
3 month
Title
Pain
Description
Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)
Time Frame
6 month
Title
ADL (Activity of daily living)
Description
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Time Frame
3 month
Title
ADL (Activity of daily living)
Description
Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)
Time Frame
6 month
Title
Rescue medication
Description
Consumption of rescue medication from diaries (mg)
Time Frame
3 month
Title
Rescue medication
Description
Consumption of rescue medication from diaries (mg)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Stiffness of joints
Description
Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
Time Frame
3 month
Title
Stiffness of joints
Description
Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)
Time Frame
6 month
Title
The volunteer evaluation of Global Disease Severity (PGAD)
Description
PGAD is measured on a 100 mm VAS scale (higher values worse)
Time Frame
3 month
Title
The volunteer evaluation of Global Disease Severity (PGAD)
Description
PGAD is measured on a 100 mm VAS scale (higher values worse)
Time Frame
6 month
Other Pre-specified Outcome Measures:
Title
SF-12 (Quality of life)
Description
Quality of life estimated on a numerical scale (1-3 and 1-6)
Time Frame
3 month
Title
SF-12 (quality of life)
Description
Quality of life estimated on a numerical scale (1-3 and 1-6)
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaj W Hansen, Prof, DMSCi
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
1958 Frb. C
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Turmeric Extract in Patients With Arthrosis.

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