Prospective, multi-center, open-label study to evaluate the effectiveness and safety of chlordiazepoxide in mild to moderate Alcohol withdrawal syndrome patients using CIWA-Ar scale in Deaddiction centers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage reduction in AWS symptoms based on daily CIWA Ar
研究概览
简要总结
Alcohol abuse is the biggest problem here: India has an estimated 160 million users of alcohol. This adds up to 14.6% of the Indian population. About 5.2% of the Indian population needs treatment for alcohol dependence. Alcohol withdrawal syndrome (AWS) occurs when patients stop drinking or significantly decrease their alcohol intake after long-term dependence. The clinical presentation varies from mild to severe, and the onset of symptoms typically occurs a few hours after the last alcohol intake. Benzodiazepines have the largest and the best evidence base in the treatment of alcohol withdrawal. Long-acting BZD are preferred and are considered as the gold standard. Chlordiazepoxide is a long-acting benzodiazepine, that is used in patients with AWS. The starting dose of Chlordiazepoxide in AWS patients usually ranges from 100-150mg/day, which is subsequently down-titrated over a period of 10-15 days and gradually withdrawn. Currently, there are limited Indian studies on safety and effectiveness of chlordiazepoxide in AWS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of more than 18 to less than 60 years Patients should be admitted in deaddiction centers after 6 hours of last alcohol use with Day 0 CIWA Ar score Patients meet criteria for mild to moderate AWS (DSM V) by the investigator Patient admitted in the deaddiction centers should be willing to give consent to participate into the trial Liver Parameters- AST or ALT less than 2 times ULN.
排除标准
- •Dependent on any substance other than alcohol except nicotine History of severe alcohol withdrawal complications (alcohol withdrawal seizures, epilepsy or delirium tremens) History of hepatic encephalopathy less than 1 year & other liver disease less than 6 months Received medications that may alter AWS presentation such as Antipsychotics other benzodiazepines (except rescue doses)) Known contraindications to chlordiazepoxide Pregnant or nursing females Patients with the inability or unwillingness to comply with the study protocol.
结局指标
主要结局
Percentage reduction in AWS symptoms based on daily CIWA Ar
时间窗: Day 0 baseline to day 12
score from baseline to day 12
时间窗: Day 0 baseline to day 12
次要结局
- LFT parameter before and at end of the study period(Number of days required for reduction of agitation and tremors)