Clinical trial NCT06359665: Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis
Official title: A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
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
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design will be a double-blind, randomized controlled trial with crossover.
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition
timeFrame: Baseline and Week 10, Week 12
Secondary outcomes:
measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition
timeFrame: Baseline and Week 10, Week 12
measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition
timeFrame: Baseline and Week 10, Week 12
measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition
timeFrame: Baseline and Week 10, Week 12
measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
timeFrame: Baseline and Week 10, Week 12
measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
timeFrame: Baseline and Week 10, Week 12
measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).
timeFrame: Baseline and Week 4
measure: Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition
timeFrame: Baseline and Week 10
measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI)
timeFrame: Baseline and Week 4, Week 6
measure: Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition
timeFrame: Baseline and Week 10, Week 12
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: Through study completion, an average of 12 weeks
measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
timeFrame: Baseline and Week 4
measure: Change from Baseline in heart rate
timeFrame: Baseline and Week 4
measure: Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
timeFrame: Week 4 and Week 6
measure: Change from Baseline in heart rate
timeFrame: Week 4 and Week 6
measure: Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR)
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum complete blood count (CBC) parameters: Hematocrit
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia Department of Plastic Surgery
name: Brent DeGeorge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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