The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- DAS28 based on erythrocyte sedimentation rate scores
研究概览
简要总结
The aim of this study is to evaluate the effectiveness and safety of Modified Zhiwang Decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.
详细描述
Rheumatoid Arthritis(RA) is a progressive inflammatory autoimmune disease characterized by chronic systemic inflammation, which can cause swelling, stiffening and articular cartilage and bone destruction. Early diagnosis and treatment in RA can improve outcomes and slow progression of joint damage. Modified Zhiwang Decoction(MZWD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of MZWD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of MZWD combined with methotrexate on early RA.
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
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16-70 years old;
- •Patients who meet the diagnostic criteria of 2010 ACR/EULAR .
- •Patients who meet the diagnostic criteria of cold pattern.
- •Disease activity score(DAS28) ≤5.2.
排除标准
- •Patients accompanied with other rheumatic diseases or severe pain due to other medical conditions, such as diabetic pain or post-herpetic neuralgia;
- •Patients with joint dysfunction and the X-ray score of wrists is grade IV;
- •Patients accompanied with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases.
- •Patients accompanied with organ injury or malignant tumors, disorders of the cardiovascular system, liver(ALT/AST>3 times higher than the upper limit of normal), kidneys(Ccr<60ml/min), brain, or hematopoietic system.
- •Pregnant and lactating women.
- •Patients are participation in any other clinical trials.
- •Patients who are allergic to the drugs used in this study.
研究组 & 干预措施
Modified Zhiwang Decoction Combined with Methotrexate
干预措施: Modified Zhiwang Decoction Combined with methotrexate (Drug)
Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
DAS28 based on erythrocyte sedimentation rate scores
时间窗: 12 weeks
DAS28 is widely accepted to evaluate RA disease activity and consists of number of tender joints out of 28, number of swollen joints out of 28, ESR and the patient's global assessment of disease activity.
次要结局
- Fatigue scale-14(12 weeks)
- Visual analogue scale pain scores(12 weeks)
- Traditional chinese medicine symptom scores(12 weeks)
- Erythrocyte sedimentation rate(12 weeks)
- C-reactive protein(12 weeks)
研究者
zhang liubo
MD
Beijing University of Chinese Medicine