Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359665
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-15
Brief Title:
Oral Curcumin for the Treatment of Pain of Thumb Base Joint CMC Arthritis
Sponsor:
Brent DeGeorge
Organization:
University of Virginia
Study Overview
Official Title:
A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None