CTRI/2014/10/005150已完成Unknown
A RANDOMISED CONTROLLED COMPARATIVE OPEN LABEL TRIAL ON THE SAFETY AND EFFICACY OF BACLOFEN WITH THAT OF DIAZEPAM IN SPASTICITY DUE TO ACQUIRED SPINAL CORD INJURIES
GOVERNMENT MEDICAL COLLEGEKOZHIKODE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月20日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IMPROVEMENT IN SPASTICITY AS OBTAINED BY IMPROVEMENT IN FUNCTIONAL INDEPENDENCE MEASURE SCORE;MONITORING ADVERSE DRUG REACTION DURING STUDY PERIOD
研究概览
简要总结
This study is a randomised controlled comparative open label trial on the safety and efficacy of baclofen 5mg tds with that of diazepam 5mg tds in spasticity due to spinal cord injuries conducted at government medical college ,kozhikode. The primary outcome measure of the study is improvement in spasticity as assessed by functional independence measure ;the adverse drug reaction is also monitored during the study period
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Written informed consent 2.Age 18 years and above 3.Patients after two months of spinal cord injury with established spasticity and not in spinal shock 4.Spasticity due to spinal cord injury of all grades 5.Spasticity interfering with sleep and functional capacity.
排除标准
- •1.Significant history of Hypersensitivity to the study drugs 2.Respiratory disorders like COPD, Sleep apnoea 3.Chronic liver disease 4.Renal disease 5.With psychiatric illness of any kind 6.Broken skin and any infections trigerring spasticity 7.Patients receiving drugs interfering significantly with the study drugs 8.Patients planned for surgical intervention 9.Glaucoma 10.Myasthenia gravis.
结局指标
主要结局
IMPROVEMENT IN SPASTICITY AS OBTAINED BY IMPROVEMENT IN FUNCTIONAL INDEPENDENCE MEASURE SCORE;MONITORING ADVERSE DRUG REACTION DURING STUDY PERIOD
时间窗: DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90
次要结局
- TO COMPARE THE ADVERSE DRUG PROFILE OF BACLOFEN WITH THAT OF DIAZEPAM(DAY 0,DAY 7,DAY 14,DAY 28,DAY 56,DAY 90)
研究者
研究点 (1)
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