The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of ACR (American College of Rheumatology) 50
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue. Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients in China for hundreds of years to relieve pain and prevent the affected joints pejorative. However, there is no systematic trials to prove the effect of NBZP for management of RA.
详细描述
A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine whether the NBZP could make an effect of pain relief and joints protection. 120 patients suffering from active RA will be enrolled and treated with NBZP or placebo for 3 months. The primary outcome measures are the rate of American College of Rheumatology (ACR) 50, changes of the Disease Activity Score (DAS) 28 from the baseline to 3 months and the van der Heijde modified Sharp score would be measured from the baseline to 12 months. The second outcome measures are the change rate of ACR20, ACR70, Health Assessment Questionnaire - Disability Index, change score of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, Patient Global Assessment of Arthritis and the Athens Insomnia Scale (AIS) from the baseline to 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months' follow-up.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
- •moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
- •an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
- •paid employment or unpaid but measurable work (e.g. caring for a family and home)
排除标准
- •combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
- •abnormal liver and my kidney function
- •pregnancy or have a plan of pregnancy,breast feeding women
- •severe chronic or acute disease interfering with therapy attendance
- •alcohol or substance abuse
研究组 & 干预措施
NiuBangZi pill group
Drug: NiuBangZi pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi pill and methotrexate
干预措施: NiuBangZi pill or NiuBangZi pill placebo (Drug)
Placeo group
Drug: NiuBangZi placebo pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi placebo pill and methotrexate
干预措施: NiuBangZi pill or NiuBangZi pill placebo (Drug)
结局指标
主要结局
Rate of ACR (American College of Rheumatology) 50
时间窗: at 3 months
changes of The Disease Activity Score (DAS) 28
时间窗: from baseline to 3 months
changes of the van der Heijde modified Sharp score
时间窗: from baseline to 3 months
次要结局
- Rate of ACR (American College of Rheumatology) 50(at 12 months)
- change score of Health Assessment Questionnaire - Disability Index(from baseline to 12 months)
- change score of Patient Assessment of Arthritis Pain(from baseline to 12 months)
- change score of Patient Global Assessment of Arthritis(from baseline to 12 months)
- change score of 36-item Short-Form Health Survey Questionnaire(from baseline to 12 months)
- changes of The Disease Activity Score (DAS) 28(from baseline to 12 months)
- rate of ACR20(at 12 months)
- change score of MOS Sleep Scale(from baseline to 12 months)
- rate of ACR70(at 12 months)
研究者
Cui xuejun
Director
Shanghai University of Traditional Chinese Medicine