NCT02264301Unknown不适用
The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis
Chengdu PLA General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年8月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in corticosteroids withdrawal rate at 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with active RA
- •without taking any other medication for the treatment of active RA in at least 4 last weeks
- •aged from 18 to 75 years
- •without conflict to the written, informed consent signed prior to the enrollment.
排除标准
- •being included in other clinical trial within the last 4 weeks
- •with abnormal liver or kidney function (more than 1 time above the high normal)
- •with serious cardiovascular disease
- •with hematologic disease
- •being in pregnancy, lactation period or under a pregnancy plan
- •with severe gastrointestinal disease
- •with contraindication or being allergic to the test drugs
- •being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs
- •being not compatible for the trial medication, or other circumstances at the discretion of investigators
- •without legal capacity or only with limited legal capacity.
研究组 & 干预措施
Puerarin injection 400 mg
Active Comparator
Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
干预措施: Puerarin injection 400 mg (Drug)
Qingkailing injection 40 ml
Experimental
Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
干预措施: Qingkailing injection 40 ml (Drug)
结局指标
主要结局
Change from baseline in corticosteroids withdrawal rate at 24 weeks
时间窗: At 0 week, 12 weeks, 24 weeks
The number (rate) of patients who do not need the use of corticosteroids any more were monitored 0 week, 12 weeks, 24 weeks.
次要结局
- Change from baseline in Disease activity score in 28 joints(DAS28)(At 0 week, 12 weeks, 24 weeks)
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Comparison of the effect of corticosteroid injection, physiotherapy and combination therapy in frozen shoulderIRCT138802011828N1Mazandaran University of Medical Sciences and Health Services105
已完成
3 期
Evaluation of the effect of corticosteroid injection in knee replacementBone Cement Implantation Syndrome.IRCT20180528039883N3Iran University of Medical Sciences200
Unknown
2 期
Carticosteroid injection combined with mobilization versus mobilization alone in sub acromial impingement syndrome.CTRI/2020/06/025692Prince Sattam Bin Abdulaziz University Al Kharj Saudi Arabia
招募中
不适用
Comparison of corticosteroid injection & extra corporeal shock wave therapy efficacy on low back pain arising from quadratus lumborum muscle.ow back pain.Low back painIRCT20100827004641N14Tabriz University of Medical Sciences54
终止
不适用
Effect of Corticosteroid Injections on Blood GlucoseSteroid DiabetesDiabetes MellitusAdhesive CapsulitisKnee OsteoarthritisShoulder OsteoarthritisHip OsteoarthritisNCT05048264Duke University38