A clinical study on effectiveness of dhattura lavana- A folklore medicine in madatyaya (Alcohol dependence)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reduce the dependency of alcohol.Parameters used to assess the reduction in dependency is by alcohol dependence scale and LFT
研究概览
简要总结
The current study will be open labeled single arm (uncontrolled) exploratory clinical trial at outpatient department and inpatient department basis with pre and post-test design. Included 30 patients will be treated with Dhattura saindhava lavana, conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, located in district headquarter in Southern India. 2.5 gram of dhattura lavana along with butter milk after food will be providing to 30 patients. The primary outcome is to reduce the dependency of alcohol in patients and the secondary outcome is to maintain the liver function within normal limits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.male or a non pregnant/non nursing female between 20 and 70 years of age.
- •2.subjects fulfilling the criteria for alcohol dependence according to ICD-
- •3.Be willing to give informed consent and comply with study procedures.
排除标准
- •Subjects suffering from organic brain diseases.
- •Subjects fulfilling ICD-10 criteria for the following axis 1 disorders: Schizophrenia, bipolar disorder, major depression or any other substance dependence disorder (excluding nicotine) •Previous withdrawal-induced delirium tremens or seizures •Presence of any serious somatic disorder e.g. liver cirrhosis •Presence of any previous heart disease of clinically significant ECG abnormality e.g. arrhythmias, bundle branch block or QT interval or T wave alterations •Use of any illegal narcotic drugs the last 30 days before screening Presence of diseases like diabetes mellitus, HIV,HbSag,Ishaemic Heart Diseases.
结局指标
主要结局
reduce the dependency of alcohol.Parameters used to assess the reduction in dependency is by alcohol dependence scale and LFT
时间窗: 37 days
次要结局
- maintain liver function within(normal limits)