A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 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 autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang(HQGZWWT)granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA.
详细描述
Investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. Investigators will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures.
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
Experimental group
Patients are given HQGZWWT granules (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
干预措施: Huang qi gui zhi wu wu granule (Drug)
Placebo group
Patients are given HQGZWWT granules placebo (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
干预措施: Huang qi gui zhi wu wu granule placebo (Drug)
结局指标
主要结局
Rate of ACR (American College of Rheumatology) 50
时间窗: at 3 months
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
changes of The Disease Activity Score (DAS) 28
时间窗: from baseline to 3 months
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
次要结局
- rate of ACR20(at 12 months)
- change score of Patient Assessment of Arthritis Pain(from baseline to 12 months)
- changes of The Disease Activity Score (DAS) 28(from baseline to 12 months)
- 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 Global Assessment of Arthritis(from baseline to 12 months)
- change score of 36-item Short-Form Health Survey Questionnaire(from baseline to 12 months)
- change score of AIS Sleep Scale(from baseline to 12 months)
- rate of ACR70(at 12 months)
研究者
Cui xuejun
Principal Investigator base of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine