An open label, single arm study on the effectiveness of individualized homoeopathic medicines for Insomnia in Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Outcome will be measured by changes in Insomnia Severity Index (ISI) every month.
研究概览
简要总结
This is an Open Label, Prospective interventional study to find out the effectiveness of Individualized Homoeopathic medicines in improving the sleep of Alcohol Dependence patients. 30 individuals aged 18 to 60, of both sexes who have symptoms of alcohol dependence (based on ICD- 10 criteria) visiting OPD and IPD of NHRIMH will be considered based on inclusion criteria. The enrollment period is for 6 months and the follow up period id for 1 year. The primary outcome will be assessed by the changes in the Insomnia Severity Index (ISI) every month. The secondary outcome will be assessed using Severity of Alcohol Dependence Questionnaire (SADQ) every month and WHO QOL BREF at the baseline and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases fulfilling the diagnostic criteria for alcohol dependence according to ICD 10 Diagnostic criteria.
- •Cases in the age group of 18 to 60 years of both the gender.
- •Score more than or equal to 8 in Insomnia Severity Index.
排除标准
- •Cases with life threatening conditions.
- •Cases with CIWA- Ar score more than
- •Cases diagnosed with other types of insomnia.
- •Cases already under psychiatric medication for insomnia.
- •Cases with co morbid psychiatric conditions.
- •Pregnant and lactating females.
结局指标
主要结局
Outcome will be measured by changes in Insomnia Severity Index (ISI) every month.
时间窗: Every month from baseline till the conclusion of the study (12th month)
次要结局
- Outcome will be measured by changes in Severity of Alcohol Dependence Questionnaire (SADQ) every month.(Every month from baseline till the conclusion of the study (12th month))
- Outcome will be measured by changes in WHO- QOL BREF scale at baseline and at the end of the study.(At the baseline and at the end of the study)
研究者
Dr Siva Tharshini K R
National Homoeopathy Research Institute in Mental Health