A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in baseline pain intensity
研究概览
简要总结
The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age or older
- •English fluency and literacy
- •Seeking care for basal joint pain
- •Tender over basal joint
- •Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
- •Radiographic evidence of Eaton stage 1 and 2 only
排除标准
- •Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
- •Inability or unwillingness to participate in a trial study
- •Rheumatoid Arthritis or other inflammatory disorder diagnoses
- •Post-traumatic osteoarthritis
- •Patients on Coumadin/Steroids/NSAIDs/Tylenol
- •Diabetes Mellitus
- •Pregnant or lactating women
- •Basal joint arthritis of Eaton stage 3
- •Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)
研究组 & 干预措施
Control
Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
干预措施: Placebo (Other)
Turmeric
Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
干预措施: Turmeric (Dietary Supplement)
结局指标
主要结局
Change in baseline pain intensity
时间窗: Enrollment, 6 weeks, and 3 months
0-10 ordinal rating of pain intensity
Change in baseline disability
时间窗: Enrollment, 6 weeks, and 3 months
Disability measured by the QuickDASH
次要结局
未报告次要终点
研究者
Neal Chung-Jen Chen
Medical Doctor
Massachusetts General Hospital