A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.
详细描述
Fang yi qing feng shi granules is the chinese patent medicine, which contains 8 kinds of chinese medicine .
Fang yi qing feng shi granules was approved by China Food and Drug Administration (CFDA) in 2005, produced by means of modern technology by Maoxiang Group Jilin Pharmaceutical Co., Ltd.The study is a multi-center, double -blind, placebo -controlled, randomized in Chinese subjects with Rheumatoid Arthritis to assess treatment effect and safety in the subjects treated with Fang yi qing feng shi granules versus subjects treated with placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have the diagnosis of Rheumatoid Arthritis in active state.
- •Subjects have the Traditional Chinese Medicine (TCM) diagnosis ofArthralgic Syndrome with the sign of dampness obstructing connecting vessel。
- •Subjects must stop the medicine at least three month，which is Diseases modifying anti-rheumatic drugs(including glucocorticoids).
- •Male or female subjects, between the ages of 18 and 65 years old.
- •Joint function grading and ray classification are both in Ⅰ～Ⅲ.
- •Subjects agree to participate in this study and sign the informed consent form.
排除标准
- •Subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.
- •Subjects with severe rheumatic arthritis are loss of ability
- •Allergic to test drugs(basic treatment or drug combination),Allergic constitution(Allergic to two or more drugs).
- •Female subject who was pregnant or breast-feeding or considering becoming pregnant.
- •Subjects with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
- •The Liver function (ALT,AST) and kidney function（BUN,Cr）is higher than normal.
- •The Blood Routine (leukocyte count,platelet count)is lower than normal.
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究组 & 干预措施
The placebo group
placebo,Oral,10g, 3 time a day ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: placebo (Drug)
High dose group
Fang yi qing feng shi granule, Oral,10g, 3 times a day, Oral,for 3 months Methotrexate,Oral,7.5-15mg per week Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Fang yi qing feng shi granule (Drug)
High dose group
Fang yi qing feng shi granule, Oral,10g, 3 times a day, Oral,for 3 months Methotrexate,Oral,7.5-15mg per week Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Methotrexate (Drug)
High dose group
Fang yi qing feng shi granule, Oral,10g, 3 times a day, Oral,for 3 months Methotrexate,Oral,7.5-15mg per week Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Acetaminophen tablets (Drug)
Low dose group
Fang yi qing feng shi granule,Oral,10g, 2 time a day, taking morning and evening,for 3 months.
placebo,Oral,10g, 1 time a day, taking noon ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Fang yi qing feng shi granule (Drug)
Low dose group
Fang yi qing feng shi granule,Oral,10g, 2 time a day, taking morning and evening,for 3 months.
placebo,Oral,10g, 1 time a day, taking noon ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: placebo (Drug)
Low dose group
Fang yi qing feng shi granule,Oral,10g, 2 time a day, taking morning and evening,for 3 months.
placebo,Oral,10g, 1 time a day, taking noon ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Methotrexate (Drug)
Low dose group
Fang yi qing feng shi granule,Oral,10g, 2 time a day, taking morning and evening,for 3 months.
placebo,Oral,10g, 1 time a day, taking noon ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Acetaminophen tablets (Drug)
The placebo group
placebo,Oral,10g, 3 time a day ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Methotrexate (Drug)
The placebo group
placebo,Oral,10g, 3 time a day ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10.
干预措施: Acetaminophen tablets (Drug)
结局指标
主要结局
The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)
时间窗: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
次要结局
- The change of Rheumatoid Arthritis (RA) associated symptoms and signs(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- The score of clinical symptoms and symptom integral(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- Change in the days and doses using of analgesic(Paracetamol Tablets)(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- The subjects of their comprehensive evaluation of disease activity(AIMS),The observer to the comprehensive evaluation of disease activity in the study(AIMS),The subjects of physical function evaluation(HAQ).(Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week)
- The change of laboratory test indexes (ESR、RF、CRP)(baseline,week12)