Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis

NCT06359665 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: HSR230544
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are:

• Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.
• Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?
• Is Turmeric safe for participants with thumb-joint arthritis? Participants will:
• take 4 weeks of daily Turmeric capsules,
• take 4 weeks of daily placebo capsules
• answer daily surveys about how they are feeling and functioning.

Conditions

Arthritis of Carpometacarpal Joint of Left Thumb; Arthritis of Carpometacarpal Joint of Right Thumb

Keywords

Thumb carpometacarpal osteoarthritis (CMC OA); Thumb carpometacarpal Osteoarthritis; turmeric; curcumin

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Pain on the Visual Analog Pain (VAS) Score

  The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report

  Baseline and Week 4, Week 6

• Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition

  The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week Change = (Week (10 or 12) Score - Baseline Score).

  Baseline and Week 10, Week 12

Secondary Outcomes (31)

• Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score

  Baseline and Week 4, Week 6

• Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition

  Baseline and Week 10, Week 12

• Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score

  Baseline and Week 4, Week 6

• Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition

  Baseline and Week 10, Week 12

• Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

  Baseline and Week 4, Week 6

Study Arms (2)

Oral curcumin

EXPERIMENTAL

Oral curcumin 500 mg capsules taken twice each day for 4 weeks.

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

Oral placebo capsules taken twice each day for 4 weeks.

Drug: Placebo

Interventions

Curcumin DRUG

500 mg capsule twice daily

Also known as: Nature Made, PharmaVite LLC, Turmeric

Oral curcumin

Placebo DRUG

capsule twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older.
• For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control:
• Norplant
• IUD (intrauterine device)
• Birth Control Patch
• Depo-Provera
• Sterilization
• The following may be used if combined with other birth control methods:
• Condoms
• Diaphragm
• Jellies or foam
• Cervical cap
• Sponge

You may not qualify if:

• Participant does not speak English.
• Participant is blind.
• Severe cardiac, pulmonary, liver, gastrointestinal and hematological disease (including coagulopathy), and /or renal disease.
• Abnormal hematological, coagulation, and/or liver function test results.
• Coumadin use at time of screening.
• Use of any anticoagulant and antiplatelet medication.
• History of mental illness.
• Participant who is incarcerated.
• History of drug or substance abuse.
• Pre-existing curcumin or turmeric product usage within 3 months of the study period.
• Participant has had a corticosteroid injection ≤ 60 days prior.
• Participant has had prior surgery for osteoarthritis treatment
• Participant who has fibromyalgia and post-operative pain.
• Females who are pregnant, nursing or planning a pregnancy
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4:

Sponsors & Collaborators

• Brent DeGeorge: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (13)

• Wolf JM, Atroshi I, Zhou C, Karlsson J, Englund M. Sick Leave After Surgery for Thumb Carpometacarpal Osteoarthritis: A Population-Based Study. J Hand Surg Am. 2018 May;43(5):439-447. doi: 10.1016/j.jhsa.2017.11.019. Epub 2018 Feb 7.

  PMID: 29428245 BACKGROUND

• Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.

  PMID: 29343479 BACKGROUND

• Funk JL, Frye JB, Oyarzo JN, Kuscuoglu N, Wilson J, McCaffrey G, Stafford G, Chen G, Lantz RC, Jolad SD, Solyom AM, Kiela PR, Timmermann BN. Efficacy and mechanism of action of turmeric supplements in the treatment of experimental arthritis. Arthritis Rheum. 2006 Nov;54(11):3452-64. doi: 10.1002/art.22180.

  PMID: 17075840 BACKGROUND

• Lakhan SE, Ford CT, Tepper D. Zingiberaceae extracts for pain: a systematic review and meta-analysis. Nutr J. 2015 May 14;14:50. doi: 10.1186/s12937-015-0038-8.

  PMID: 25972154 BACKGROUND

• Goel A, Kunnumakkara AB, Aggarwal BB. Curcumin as "Curecumin": from kitchen to clinic. Biochem Pharmacol. 2008 Feb 15;75(4):787-809. doi: 10.1016/j.bcp.2007.08.016. Epub 2007 Aug 19.

  PMID: 17900536 BACKGROUND

• Daily JW, Yang M, Park S. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Med Food. 2016 Aug;19(8):717-29. doi: 10.1089/jmf.2016.3705.

  PMID: 27533649 BACKGROUND

• Travica N, Teasdale S, Marx W. Nutraceuticals in mood disorders: current knowledge and future directions. Curr Opin Psychiatry. 2023 Jan 1;36(1):54-59. doi: 10.1097/YCO.0000000000000826. Epub 2022 Aug 29.

  PMID: 36044293 BACKGROUND

• Hafez Ghoran S, Calcaterra A, Abbasi M, Taktaz F, Nieselt K, Babaei E. Curcumin-Based Nanoformulations: A Promising Adjuvant towards Cancer Treatment. Molecules. 2022 Aug 16;27(16):5236. doi: 10.3390/molecules27165236.

  PMID: 36014474 BACKGROUND

• Zeng L, Yang T, Yang K, Yu G, Li J, Xiang W, Chen H. Efficacy and Safety of Curcumin and Curcuma longa Extract in the Treatment of Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trial. Front Immunol. 2022 Jul 22;13:891822. doi: 10.3389/fimmu.2022.891822. eCollection 2022.

  PMID: 35935936 BACKGROUND

• Bannuru RR, Osani MC, Al-Eid F, Wang C. Efficacy of curcumin and Boswellia for knee osteoarthritis: Systematic review and meta-analysis. Semin Arthritis Rheum. 2018 Dec;48(3):416-429. doi: 10.1016/j.semarthrit.2018.03.001. Epub 2018 Mar 10.

  PMID: 29622343 BACKGROUND

• Hsiao AF, Lien YC, Tzeng IS, Liu CT, Chou SH, Horng YS. The efficacy of high- and low-dose curcumin in knee osteoarthritis: A systematic review and meta-analysis. Complement Ther Med. 2021 Dec;63:102775. doi: 10.1016/j.ctim.2021.102775. Epub 2021 Sep 16.

  PMID: 34537344 BACKGROUND

• Wang Z, Singh A, Jones G, Winzenberg T, Ding C, Chopra A, Das S, Danda D, Laslett L, Antony B. Efficacy and Safety of Turmeric Extracts for the Treatment of Knee Osteoarthritis: a Systematic Review and Meta-analysis of Randomised Controlled Trials. Curr Rheumatol Rep. 2021 Jan 28;23(2):11. doi: 10.1007/s11926-020-00975-8.

  PMID: 33511486 BACKGROUND

• Kuptniratsaikul V, Dajpratham P, Taechaarpornkul W, Buntragulpoontawee M, Lukkanapichonchut P, Chootip C, Saengsuwan J, Tantayakom K, Laongpech S. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study. Clin Interv Aging. 2014 Mar 20;9:451-8. doi: 10.2147/CIA.S58535. eCollection 2014.

  PMID: 24672232 BACKGROUND

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Brent DeGeorge, MD, PhD

  University of Virginia Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Randomized Controlled Trial
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Plastic Surgery

Model Details: The study design will be a double-blind, randomized controlled trial with crossover.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 11, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)