A clinical study to evaluate the efficacy of Ayurveda treatment protocol in madatyaya w.s.r. to alcohol use disorder – A black box study
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 Score of the CIWA-Ar Scale and Insomnia Severity Index.
研究概览
简要总结
Madatyaya is described very well in Ayurvedic texts. It can be compared with Alcohol Use Disorder(AUD) in accordance with the modern science. Hence, An Ayurveda treatment protocol will be tested in this study to check its efficacy in the management of patients diagnosed with AUD considering inclusion criteria. Worldwide accepted standard scales like AUDIT, CIWA Ar, ISI, WHO QOL BREF will be used in this study for diagnosis, inclusion and assessment. The present Ayurveda treatment protocol includes Kharjuraji mantha, Ashwagandha arishta, Bramha rasayan, Til tail shirobasti, yoga and Satvavajaya Chikitsa. 30 patients will be studied in a single group for 30 days along with follow up after 15 days. Observations will be gathered and statistically tested to get final results, upon which proposed research question will be tested.
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
- •Inclusion Criteria
- •Patients who have a mild to moderate range (Score 0-15) of CIWA-Ar Scale
- •Patients of either sex in the age range of 18–60 years, irrespective of caste, religion, economic status, and marital status.
- •Patients who are not receiving any contemporary de-addiction treatment.
排除标准
- •Exclusion Criteria
- •Patient with a severe range (more than15) of symptoms CIWA-Ar Scale
- •Patients with potentially co-morbid diseases like Coronary Artery Disease (CAD), malignancy, renal failure, Liver Disease (III, IV- Stage), Heart failure etc.
- •Patients with significant psychiatric co-morbidity (e.g. schizophrenia, major depressive disorder, or severe anxiety Disorder).
- •Pregnant and lactating mothers.
- •Patients with a history of multiple drug addictions.
结局指标
主要结局
Changes in Score of the CIWA-Ar Scale and Insomnia Severity Index.
时间窗: 30 days+ 15 days follow up
次要结局
- 1.Changes in the Signs and Symptoms of Madatyaya.(2.Change in levels of CBC, and LFT.)
研究者
Khandizod Sandesh Suresh
PG Department of Agad Tantra, IAS&R, Shri Krishna AYUSH University, Kurukshetra