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Completed

NCT Number: NCT04500210

Comparative Study of Turmeric Extract in Patients With Arthrosis.

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.

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Key information

Conditions

Arthralgia Disturbance of Activity and Attention Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Stiffness of Unspecified Joint, Not Elsewhere Classified

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, 1958 Frb. C, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo in gelatin capsules

Turmeric

Dietary Supplement

Turmeric in gelatin capsules

Primary outcomes

  1. Pain

    Time frame: 3 month

    Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)

  2. Pain

    Time frame: 6 month

    Difference in WOMAC pain on a 100 mm VAS scale (high levels worse)

  3. ADL (Activity of daily living)

    Time frame: 3 month

    Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)

  4. ADL (Activity of daily living)

    Time frame: 6 month

    Difference in WOMAC ADL on a 100 mm VAS scale (high levels worse)

  5. Rescue medication

    Time frame: 3 month

    Consumption of rescue medication from diaries (mg)

  6. Rescue medication

    Time frame: 6 month

    Consumption of rescue medication from diaries (mg)

Secondary outcomes

  1. Stiffness of joints

    Time frame: 3 month

    Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)

  2. Stiffness of joints

    Time frame: 6 month

    Difference in stiffness of joints on a 100 mm VAS scale (higher values worse)

  3. The volunteer evaluation of Global Disease Severity (PGAD)

    Time frame: 3 month

    PGAD is measured on a 100 mm VAS scale (higher values worse)

  4. The volunteer evaluation of Global Disease Severity (PGAD)

    Time frame: 6 month

    PGAD is measured on a 100 mm VAS scale (higher values worse)

Other outcomes

  1. SF-12 (Quality of life)

    Time frame: 3 month

    Quality of life estimated on a numerical scale (1-3 and 1-6)

  2. SF-12 (quality of life)

    Time frame: 6 month

    Quality of life estimated on a numerical scale (1-3 and 1-6)

Sponsors and collaborators

Lead sponsor

Kaj Winther Hansen

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2020
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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