A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF BACLOFEN AND CHLORDIAZEPOXIDE IN ALCOHOL WITHDRAWAL SYNDROME
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of baclofen with chlordiazepoxide in AWS as assessed by Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar score).
研究概览
简要总结
This is a open label, randomized, controlled, two arm clinical trial to compare the efficacy and tolerability of baclofen and chlordiazepoxide in alcohol withdrawal syndrome, Baclofen 10 mg will be administered in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days and Chlordiazepoxide at a dose of 25mg in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days. The efficacy of study drugs will be assessed everyday using CIWA-Ar scale and adverse effects will be recorded. Lorazepam/Haloperidol (IM) will be used as rescue medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with alcohol dependence according to DSM-IV (TR) criteria.
- •Last alcohol intake within 24 hour preceding the initiation of study.
- •Willingness to give written informed consent.
排除标准
- •Patients with known psychiatric disorders.
- •Patients with known renal and cardiovascular diseases.
- •Patients with known allergy to study medications.
- •Patients with multi-drug abuse.
- •Patients with any other substance dependence except nicotine.
- •Patients with delirium tremens.
结局指标
主要结局
To compare the efficacy of baclofen with chlordiazepoxide in AWS as assessed by Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar score).
时间窗: 10 days
Primary Outcome: lowering in CIWA-Ar severity scores.
时间窗: 10 days
次要结局
- Clinical Global Impression(CGI) Scales.(1.Decrease in CGI-severity scale.)