COMPARATIVE CLINICAL STUDY OF TIL TAILA SHIRODHARA AND KSHEER SHIRODHARA IN MADATYAYA JANYA ANIDRA W.S.R.TO ALCOHOL WITHDRAWAL SYNDROME
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
- Changes in sleep quality
研究概览
简要总结
This trial will be done to compare clinical efficacy of Til Taila Shirodhara and Ksheer Shirodhara in management of Madatyaya janya anidra with special reference to Alcohol Withdrawal Syndrome. This is an interventional clinical trial with sample size of 30 with 2 groups. Each group having a sample size of 15 patients. In group A Til Taila Shirodhara will be done for duration of 45 minutes for 14 days. The time of administration will be morning (8 -11 AM). In group B Ksheer Shirodhara will be done for duration of 45 minutes for 14 days. The time of administration will be morning (8 -11 AM). The assessment of the clinical response in the total number of patients will be made on : The insomnia assessment criteria, insomnia screening questionnaire, Clinical assessment of alcohol withdrawal Patients (CIWA). Patient will be further followed up on Fourteenth day after the completion of the trial.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patient of alcohol addiction.
- •Clinical manifestation of insomnia as a alcohol withdrawal syndrome which will be presented at that time.
- •Age between 20-60 years
- •Either sex.
排除标准
- •1.Alcohol addicted patients suffering from liver failure, gastrointestinal bleeding, cerebellar degeneration.
- •2.Alcohol addicted patients who are suffering from major psychiatric disorders like Bipolar disorder.
- •3.Alcohol addicted patients suffering from major systemic illness like diabetes, hypertension, myocardial infarction, ischemic heart disease, pulmonary tuberculosis etc.
结局指标
主要结局
Changes in sleep quality
时间窗: 28 days
次要结局
- Changes in Parameters of Madatyaya janya Anidra(28 days)