Comparative Study of Turmeric Extract in Patients With Arthrosis.

NCT04500210 | Completed Phase 3

• 1 other identifier: Tr-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Arthralgia, stiffness of joints, quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Stiffness of joints

  3 month

• Stiffness of joints

  6 month

• The volunteer evaluation of Global Disease Severity (PGAD)

  3 month

• The volunteer evaluation of Global Disease Severity (PGAD)

  6 month

Other Outcomes (2)

• SF-12 (Quality of life)

  3 month

• SF-12 (quality of life)

  6 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

one capsule daily

Dietary Supplement: Placebo

Turmeric extract

ACTIVE COMPARATOR

one capsule daily

Dietary Supplement: Turmeric

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo in gelatin capsules

Placebo

Turmeric DIETARY_SUPPLEMENT

Turmeric in gelatin capsules

Turmeric extract

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteers
• years of age or more
• Osteoarthritis of the hip and or the knee
• Suffering from pain in the hip and or knee -

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaj Winther Hansen: lead

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, 1958 Frb. C, Denmark

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Kaj W Hansen, Prof, DMSCi

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor, MD, DMsCi

Model Details: Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: August 5, 2020
• Study Start: January 1, 2020
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: October 25, 2021

Record last verified: 2020-07

Locations

DK (1)