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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form. 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:

1. Participant does not speak English. 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06359665
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brent DeGeorge
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brent DeGeorge, MD, PhD
Principal Investigator Affiliation University of Virginia Department of Plastic Surgery
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis of Carpometacarpal Joint of Left Thumb, Arthritis of Carpometacarpal Joint of Right Thumb
Additional Details

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.

Arms & Interventions

Arms

Experimental: Oral curcumin

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

Placebo Comparator: Placebo

Oral placebo capsules taken twice each day for 4 weeks.

Interventions

Drug: - Curcumin

500 mg capsule twice daily

Drug: - Placebo

capsule twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Virginia, Charlottesville, Virginia

Status

Address

University of Virginia

Charlottesville, Virginia, 22903