Arthritis of Carpometacarpal Joint of Left ThumbPhase 1NCT06359665
Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis
A Phase 1 study testing Curcumin in people with Arthritis of Carpometacarpal Joint of Left Thumb and Arthritis of Carpometacarpal Joint of Right Thumb, run by Brent DeGeorge at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of Carpometacarpal Joint of Left Thumb, Arthritis of Carpometacarpal Joint of Right Thumb
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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
- 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
- Daily visual analog pain greater than 5 and ≤ 9 out of 10.
- Duration of pain for greater than 30 days.
- Presence of radiographically confirmed diagnosis of thumb basal joint arthritis
Who cannot join
- 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.
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- 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:
- Itraconazole,
- Ketoconazole,
- Azamulin,
- Troleandomycin,
- Verapamil,
- John's wart,
- Phenobarbital,
- Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:
- Nootkatone,
- Ticlopidine,
- Rifampin,
- Omeprazole),
- Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C8:
- Montelukast,
- Quercetin,
- Phenelzine,
- Rifampin,
- Clopidogrel ,
- 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,
- 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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis
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?
Read more
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.
Read the detailed description
This randomized controlled trial of oral curcumin for the treatment of pain of CMC arthritis will investigate the therapeutic potential of curcumin as an oral treatment for pain of CMC arthritis. Rationale: Curcumin 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 CMC arthritis. Hypothesis: Curcumin is more effective than placebo for relieving pain and improving patient-reported outcomes for CMC arthritis Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the Curcumin or control and then crossover to the other condition for 4 additional weeks. Patients will take the oral curcumin or control placebo capsule twice daily. Subjects will be advised to observe adverse effects.
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
- Arthritis of Carpometacarpal Joint of Left Thumb, Arthritis of Carpometacarpal Joint of Right Thumb
- Being tested
- Curcumin, Placebo
- Keywords
- Thumb carpometacarpal osteoarthritis (CMC OA), Thumb carpometacarpal Osteoarthritis, turmeric, curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Nature Made, PharmaVite LLC, Turmeric
500 mg capsule twice daily
PlaceboDrug
capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oral curcumin | Experimental | Oral curcumin 500 mg capsules taken twice each day for 4 weeks. Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Oral placebo capsules taken twice each day for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Baseline and Week 10, Week 12
Secondary outcomes (31)
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)
Measured: Baseline and Week 4, Week 6
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week 10, Week 12 Score - Baseline Score)
Measured: 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
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)
Measured: 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
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (10 or 12) Score - Baseline Score)
Measured: Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)
Measured: Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (10, 12) Score - Baseline Score)
Measured: Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)
Measured: Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (10, 12) Score - Baseline Score)
Measured: Baseline and Week 10, Week 12
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)
Measured: Baseline and Week 4, Week 6
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (10, 12) Score - Baseline Score)
Measured: Baseline and Week 10, Week 12
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)
Measured: Baseline and Week 4
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 10 Score - Baseline Score)
Measured: Baseline and Week 10
Change from Baseline in perseverance on the Brief Resilience Index (BRI)
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)
Measured: Baseline and Week 4, Week 6
Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (10, 12) Score - Baseline Score)
Measured: Baseline and Week 10, Week 12
Number of Participants With Treatment-Related Adverse Events
Treatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit
Measured: Through study completion, an average of 12 weeks
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Measured: Baseline and Week 4
Change from Baseline in heart rate
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Measured: Baseline and Week 4
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Measured: Week 4 and Week 6
Change from Baseline in heart rate
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Measured: Week 4 and Week 6
Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)
Change from baseline in serum liver panel parameters: ALT, ALP and AST (International units per liter) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, BUN, Creatinine, Calcium (mg/dL) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR)
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: eGFR (mL/min/1.73m2) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin (umol/L) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide (meq/L) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin (g/dL) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT (seconds)-INR) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets
Change from baseline in serum complete blood count (CBC) parameters: RBC, WBC, Platelets (uL) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin (g.dL) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit (percentage) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) (pg) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)
Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) (pg) at baseline and follow up
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Arthritis of Carpometacarpal Joint of Left ThumbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design will be a double-blind, randomized controlled trial with crossover.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brent DeGeorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brent DeGeorge, University of Virginia
- Investigators
- Brent DeGeorge, MD, PhD, Principal investigator, University of Virginia Department of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359665
- Sponsor's protocol ID
- HSR230544
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29428245Brat 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.
PubMed 29343479Funk 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.
PubMed 17075840Lakhan 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.
PubMed 25972154Goel 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.
PubMed 17900536Daily 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.
PubMed 27533649Travica 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.
PubMed 36044293Hafez 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.
PubMed 36014474Zeng 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.
PubMed 35935936Bannuru 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.
PubMed 29622343Hsiao 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.
PubMed 34537344Wang 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.
PubMed 33511486Kuptniratsaikul 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.
PubMed 24672232
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis
- ClinicalTrials.gov ID
- NCT06359665
- Acronym / sponsor ID
- HSR230544
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brent DeGeorgeUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial of oral curcumin for the treatment of pain of CMC arthritis will investigate the therapeutic potential of curcumin as an oral treatment for pain of CMC arthritis. Rationale: Curcumin 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 CMC arthritis. Hypothesis: Curcumin is more effective than placebo for relieving pain and improving patient-reported outcomes for CMC arthritis Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the Curcumin or control and then crossover to the other condition for 4 additional weeks. Patients will take the oral curcumin or control placebo capsule twice daily. Subjects will be advised to observe adverse effects.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design will be a double-blind, randomized controlled trial with crossover.
| Arm | Type | Receives |
|---|---|---|
| Oral curcumin | Experimental | Drug: CurcuminOral curcumin 500 mg capsules taken twice each day for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo capsules taken twice each day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- 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:
Key exclusion criteria (60 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: Nature Made, PharmaVite LLC, Turmeric500 mg capsule twice daily | Drug | Oral curcumin |
| Placebocapsule twice daily | Drug | Placebo |
Primary outcome
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
Time frame: Baseline and Week 4, Week 6
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
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition
Time frame: Baseline and Week 10, Week 12
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).
31 secondary outcomes
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
Time frame: Baseline and Week 4, Week 6
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time frame: Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition
Time frame: Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
Time frame: Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
Time frame: Baseline and Week 10, Week 12
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
Time frame: Baseline and Week 4, Week 6
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
Time frame: Baseline and Week 10, Week 12
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).
Time frame: Baseline and Week 4
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition
Time frame: Baseline and Week 10
Change from Baseline in perseverance on the Brief Resilience Index (BRI)
Time frame: Baseline and Week 4, Week 6
Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition
Time frame: Baseline and Week 10, Week 12
Number of Participants With Treatment-Related Adverse Events
Time frame: Through study completion, an average of 12 weeks
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Time frame: Baseline and Week 4
Change from Baseline in heart rate
Time frame: Baseline and Week 4
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Time frame: Week 4 and Week 6
Change from Baseline in heart rate
Time frame: Week 4 and Week 6
Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR)
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)
Time frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)
Time frame: Through study completion, an average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 29428245Wolf 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.
- Background: PubMed 29343479Brat 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.
- Background: PubMed 17075840Funk 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.
- Background: PubMed 25972154Lakhan 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.
- Background: PubMed 17900536Goel 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.
- Background: PubMed 27533649Daily 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.
- Background: PubMed 36044293Travica 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.
- Background: PubMed 36014474Hafez 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.
- Background: PubMed 35935936Zeng 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.
- Background: PubMed 29622343Bannuru 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.
- Background: PubMed 34537344Hsiao 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.
- Background: PubMed 33511486Wang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brent DeGeorge, MD, PhD principal investigator
University of Virginia Department of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin in people with Arthritis of Carpometacarpal Joint of Left Thumb and Arthritis of Carpometacarpal Joint of Right Thumb, run by Brent DeGeorge at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 60 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score (time frame: Baseline and Week 4, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06359665, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.