NCT06359665

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

A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Brent DeGeorge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis of Carpometacarpal Joint of Left Thumb
• Arthritis of Carpometacarpal Joint of Right Thumb

Interventions

Type	Name	Description
DRUG	Curcumin	500 mg capsule twice daily
DRUG	Placebo	capsule twice daily

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-04-11
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study