Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis
NCT ID: NCT06359665
Last Updated: 2025-12-19
Study Results
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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ENROLLING_BY_INVITATION
PHASE1
100 participants
INTERVENTIONAL
2025-02-01
2026-02-28
Brief Summary
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* 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.
Detailed Description
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The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the case (curcumin) or control capsules and then crossover to the other condition for 4 more weeks with a 2-week washout interval between. Patients will take one oral capsule by mouth twice daily. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe adverse events are noticed, the patient's will discontinue the use of the capsules, and appropriate care and observation will be taken. Each condition will last for 4 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition following a 2-week washout period. To capture any delayed-onset adverse events, subjects will attend a follow-up visit seven days following the last dose of the curcumin capsule.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Oral curcumin
Oral curcumin 500 mg capsules taken twice each day for 4 weeks.
Curcumin
500 mg capsule twice daily
Placebo
Oral placebo capsules taken twice each day for 4 weeks.
Placebo
capsule twice daily
Interventions
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Curcumin
500 mg capsule twice daily
Placebo
capsule twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18 years or older.
4. 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
5. For males, must be willing to not father a baby for the duration of the study and for 90 days after the last dose of study drug, or donate to a sperm back during this time. Must be willing to use an approved form of birth control during this time. Acceptable forms of birth control:
* Condoms
* Sterilization
6. Daily visual analog pain greater than 5 and ≤ 9 out of 10.
7. Duration of pain for greater than 30 days.
8. Presence of radiographically confirmed diagnosis of thumb basal joint arthritis
Exclusion Criteria
2. Participant is blind.
3. Severe cardiac, pulmonary, liver, gastrointestinal and hematological disease (including coagulopathy), and /or renal disease.
4. Abnormal hematological, coagulation, and/or liver function test results.
5. Coumadin use at time of screening.
6. Use of any anticoagulant and antiplatelet medication.
7. History of mental illness.
8. Participant who is incarcerated.
9. History of drug or substance abuse.
10. Pre-existing curcumin or turmeric product usage within 3 months of the study period.
11. Participant has had a corticosteroid injection ≤ 60 days prior.
12. Participant has had prior surgery for osteoarthritis treatment
13. Participant who has fibromyalgia and post-operative pain.
14. Females who are pregnant, nursing or planning a pregnancy
15. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4:
* Itraconazole,
* Ketoconazole,
* Azamulin,
* Troleandomycin,
* Verapamil,
* John's wart,
* Phenobarbital,
16. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:
* Nootkatone,
* Ticlopidine,
* Rifampin,
* Omeprazole),
17. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C8:
* Montelukast,
* Quercetin,
* Phenelzine,
* Rifampin,
* Clopidogrel ,
18. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C9:
* Sulfaphenazole,
* Tienilic acid,
* Carbamazepine,
* Apoflutamide ,
* Fluconazole,
* Celecoxib,
19. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP1A2:
* alpha-Naphthoflavone,
* Furafylline,
* Phenytoin,
* Rifampin,
* Ritonavir,
* smoking,
* Teriflunomide,
* Ciprofloxacin,
* oral contraceptives,
* Allopurinol
20. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2B6 :
* Sertraline,
* Phencyclidine,
* Thiotepa,
* Ticlopidine,
* Carbamazepine,
* Efavirenz,
* Rifampin,
* Bupropion)
18 Years
ALL
No
Sponsors
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Brent DeGeorge
OTHER
Responsible Party
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Brent DeGeorge
Associate Professor of Plastic Surgery
Principal Investigators
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Brent DeGeorge, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Department of Plastic Surgery
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HSR230544
Identifier Type: -
Identifier Source: org_study_id