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临床试验/CTRI/2025/11/097406
CTRI/2025/11/097406
尚未招募
不适用

A Pilot clinical study to evaluate the effect of Aswagandha Ksheera shirodhara in insomnia disorders w s r to EEG and sleep indices

Dr Sruthi k1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年11月22日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Dr Sruthi k
入组人数
12
试验地点
1
主要终点
Changes in the following variables will be noted

概览

简要总结

Adequate sleep is one of the essential factors to lead a healthy life. In another words if normal sleep is disturbed for a short time, it can be managed but if it continues for a prolonged period then the condition is called as a disease which can be termed on the basis of its characteristics like sleep disorder, insomnia  etc. The ICSD-3  is built on the same basic outline as the ICSD-2 ,Identifying seven major categories that include insomnia disorders ,sleep related breathing disorders ,central disorders of hypersomnolence, circadian rhythm sleep -wake disorders ,sleep related movement disorders, parasomnias, and other sleep disorders. Insomnia disorder affect large proportion of population on a situational ,recurrent or chronic basis and is among the most common complaints of medical practice, is predominantly characterized by dissatisfaction with sleep duration or quality and difficulties initiating or maintaining sleep, along with substantial distress and impairment of day time functioning In ayurveda it can  be correlated as nidranasha, anidra, etc. Nidra is one among the trayo upastambha, hence it is needed for  normal body function. It is an adharaneeya vega and for the management of disease due to suppression of the urge of sleep, one should resort to sound sleep and massage. Nidranasha is a vataja nanatmaja vikara, mainly caused by vata dosha, in which Murdhni taila is mentioned as one of its treatment.

Murdhini taila consist of four different procedures such as abhyanga, seka, pichu and vastiShiro dhara is comes under Murdhini taila.It is a classical and well established ayurvedic procedure of slowly and steadily dripping medicated oil or other liquids on the forehead.There are numerous studies claiming effectiveness in insomnia with ayurveda interventions but the scientific validation remain largely unexplained. The main reason being difficulty to accessing affordable technology The objective of this study is to evaluate aswagandha ksheera shiro dhara in insomnia disorders is effective in inducing EEG changes. As this is a pilot study, A total number of 12 participants having insomnia disorder administrated shirodhara .Pre and post treatment, PSG will be evaluated along with sleep indices

Key words- Shiro dhara, Insomnia disorders, Electro encephalo gram (EEG),Polysomnography (PSG)

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Participants fullfilling the diagnostic criteria 2.Between the age group of 20 to 60 years 3.Participants willing to give informed consent.

排除标准

  • 1.Active infections on scalp 2.Allergic rhinitis and fever 3.Insomnia due to substance abuse 4.Taking any medication that could cause sedation and cause insomnia 5.Taking pain killers contain caffeine 6.Psychiatric and epileptic patients with and without medications 7.Other physical signs such as dementia or any space occupying lesion.

结局指标

主要结局

Changes in the following variables will be noted

时间窗: 0th day,15th day in case of sleep indices and polysomnography

1.Insomnia Severity Index 1st

时间窗: 0th day,15th day in case of sleep indices and polysomnography

and 15th day

时间窗: 0th day,15th day in case of sleep indices and polysomnography

2.Pittsburgh sleep quality

时间窗: 0th day,15th day in case of sleep indices and polysomnography

index 1st and 15th day

时间窗: 0th day,15th day in case of sleep indices and polysomnography

3.Event Evaluation scale

时间窗: 0th day,15th day in case of sleep indices and polysomnography

accessed daily

时间窗: 0th day,15th day in case of sleep indices and polysomnography

4.Polysomnography 0th,15 th day

时间窗: 0th day,15th day in case of sleep indices and polysomnography

次要结局

未报告次要终点

研究者

发起方
Dr Sruthi k
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sruthi K

Government Ayurveda College Thiruvananthapuram

研究点 (1)

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