A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind Randomized Controlled Trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •IUD (intrauterine device)
- •Birth Control Patch
- •Depo-Provera
- •Sterilization
- •The following may be used if combined with other birth control methods:
- •Diaphragm
- •Jellies or foam
- •Cervical cap
- •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:
- •Sterilization
- •Daily visual analog pain greater than 5 and ≤ 9 out of
- •Duration of pain for greater than 30 days.
- •Presence of radiographically confirmed diagnosis of thumb basal joint arthritis
排除标准
- •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.
- •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,
- •Teriflunomide,
- •Ciprofloxacin,
- •oral contraceptives,
- •Allopurinol
- 另有 9 项未显示
研究组 & 干预措施
Oral curcumin
Oral curcumin 500 mg capsules taken twice each day for 4 weeks.
干预措施: Curcumin (Drug)
Placebo
Oral placebo capsules taken twice each day for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
时间窗: 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
时间窗: 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).
次要结局
- Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index(Baseline and Week 10, Week 12)
- Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure(Week 4 and Week 6)
- Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)(Through study completion, an average of 12 weeks)
- Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score(Baseline and Week 4, Week 6)
- Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition(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 - crossover condition(Baseline and Week 10, Week 12)
- Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score(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(Baseline and Week 10, Week 12)
- Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).(Baseline and Week 4)
- Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition(Baseline and Week 10)
- Change from Baseline in perseverance on the Brief Resilience Index (BRI)(Baseline and Week 4, Week 6)
- Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition(Baseline and Week 10, Week 12)
- Number of Participants With Treatment-Related Adverse Events(Through study completion, an average of 12 weeks)
- Change from Baseline in heart rate(Week 4 and Week 6)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium(Through study completion, an average of 12 weeks)
- Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score(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(Baseline and Week 10, Week 12)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR)(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin(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(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin(Through study completion, an average of 12 weeks)
- Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide(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)(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Hematocrit(Through study completion, an average of 12 weeks)
- Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)(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)(Through study completion, an average of 12 weeks)
研究者
Brent DeGeorge
Associate Professor of Plastic Surgery
University of Virginia