CTRI/2023/10/058249尚未招募3 期
A controlled clinical study to evaluate the effect of Ashwagandha ksheerapaka in the management of Anidra w.s.r. to Primary Insomnia.
Dr Rushikesh Dilip Chalak1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of trail drug over anidra (primary insomnia) is assessed by the Pittsburgh Sleep Quality index and Patients mental status
研究概览
简要总结
- Insomnia is a sleep disorder that regularly effects millions of people world wide. It leads to day time sleep, lethargy and general felling of being unwell. It affects both physical and mental status. Insomnia is difficulty to initiate and maintain sleep or waking to early.
- In Ayurveda it named as Anidra/Nidranasha under different disorder and condition.
- Objectives of study are to evaluate the effect of Ashwagandha Ksheerpaka and compare it to the Jatipatri Ksheerpaka effect in the management of Anidra.
- This is a randomized comparative clinical study. Total 40 patients of Anidra will be selected and randomly divided into two groups A and B. Group A will be given Ashwagandha Ksheerpaka and Group B given Jatipatri Ksheerapaka.
- The Pittsburgh Sleep Quality Index (PSQI) and Ayurvedic adopted scale selected for assessment criteria. Total Study duration will be 45 days and contain 4 visits (0th day, 15th day,30th day, 45day), which includes administration of trial drug for 30 days and post medication follow up on 45th day.
- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis of results, conclusion will be drawn.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with classical sign & symptoms of Anidra 2.Patient who are fulfilling the American Psychiatric Association (DSM-IV) diagnostic criteria of Primary Insomnia.
- •3.Patient with On-going medication of other systemic disorders which does not interfere with the current course of insomnia will be included in the study.
排除标准
- •Patient with Secondary Insomnia.
- •2.Patient with Alcohol dependency.
- •3.Patient suffering with major psychiatric disorders and other Systemic disorders.
- •4.Patient on Hypnotic medications, sedative drugs or any other drugs which causes drowsiness.
- •5.Patient with Lactose intolerance.
- •6.Pregnant and lactating women will be excluded.
- •7.Patient denying consent.
结局指标
主要结局
Effect of trail drug over anidra (primary insomnia) is assessed by the Pittsburgh Sleep Quality index and Patients mental status
时间窗: 15day, 30 day, 45 day
次要结局
- Safety of trial drug & adverse drug reaction, aggravation of the symptoms of the symptoms of Anidra (Primary Insomnia).(15day 30day 45day)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the CerebellumInsomnia DisorderNCT05992285Xijing Hospital68
已完成
不适用
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for InsomniaSleep DisturbanceInsomniaNCT04452981Neurovalens Ltd.153
尚未招募
Unknown
Role of drug "Tagaradi kwath" in the management of Anidra (Insomnia)CTRI/2021/09/036371Self30
招募中
3 期
Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary InsomniaInsomniaNCT05615727The University of Hong Kong20
尚未招募
2 期
A Clinical trial to study the effect of SDLSNT21 tablet in Patients of Nidranash(Insomnia).CTRI/2023/02/049355Dean Faculty of Ayurved90