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Trial record 3 of 111 for:    Turmeric

Turmeric for Patients With Basal Joint Arthritis

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ClinicalTrials.gov Identifier: NCT03017118
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

Brief Summary:
The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.

Condition or disease Intervention/treatment Phase
Thumb Osteoarthritis Dietary Supplement: Turmeric Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Turmeric
Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
Dietary Supplement: Turmeric
Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.

Placebo Comparator: Control
Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
Other: Placebo
Subjects in the control group will receive a placebo 3 times per day for 6 weeks.




Primary Outcome Measures :
  1. Change in baseline pain intensity [ Time Frame: Enrollment, 6 weeks, and 3 months ]
    0-10 ordinal rating of pain intensity

  2. Change in baseline disability [ Time Frame: Enrollment, 6 weeks, and 3 months ]
    Disability measured by the QuickDASH



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years of age or older
  • English fluency and literacy
  • Seeking care for basal joint pain
  • Tender over basal joint
  • Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
  • Radiographic evidence of Eaton stage 1 and 2 only

Exclusion Criteria:

  • Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
  • Inability or unwillingness to participate in a trial study
  • Rheumatoid Arthritis or other inflammatory disorder diagnoses
  • Post-traumatic osteoarthritis
  • Patients on Coumadin/Steroids/NSAIDs/Tylenol
  • Diabetes Mellitus
  • Pregnant or lactating women
  • Basal joint arthritis of Eaton stage 3
  • Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017118


Contacts
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Contact: Neal Chen, M.D. 617-726-4700 nchen1@mgh.harvard.edu
Contact: Rachel Gottlieb, BSc 6177261569 rgottlieb3@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Neal Chen, MD    617-726-4700    nchen1@mgh.harvard.edu   
Contact: Rachel Gottlieb, BSc    6177261569    rgottlieb3@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Neal Chen, MD Massachusetts General Hospital

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Responsible Party: Neal Chung-Jen Chen, Medical Doctor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03017118     History of Changes
Other Study ID Numbers: 2016P001402
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs