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Comparative Study of Turmeric Extract in Patients With Arthrosis.

NCT ID: NCT04500210

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-09-07

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

one capsule daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo in gelatin capsules

Turmeric extract

one capsule daily

Group Type ACTIVE_COMPARATOR

Turmeric

Intervention Type DIETARY_SUPPLEMENT

Turmeric in gelatin capsules

Interventions

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Placebo

Placebo in gelatin capsules

Intervention Type DIETARY_SUPPLEMENT

Turmeric

Turmeric in gelatin capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaj Winther Hansen

OTHER

Sponsor Role lead

Responsible Party

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Kaj Winther Hansen

professor, MD, DMsCi

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kaj W Hansen, Prof, DMSCi

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Tr-01

Identifier Type: -

Identifier Source: org_study_id