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临床试验/CTRI/2025/03/081874
CTRI/2025/03/081874尚未招募不适用

RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ACUPUNCTURE IN INSOMNIA WITH SPECIAL REFERENCE TO ANIDRA

Dr vinod1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Significant improvement in quality of sleep based on Brief Psychiatric Rating Scale and PSQI Score.

研究概览

简要总结

Nidra is one among the three Upasthambas for the maintenance of the living organism. Nidra is a natural state of rest for the mind and body, involving partial or complete loss of consciousness with closed eyes. Anidra is a sleep disturbance linked to Insomnia, characterized by difficulty initiating, maintaining, or improving sleep, leading to daytime impairment. Approximately 10% of the adult population suffers from an Insomnia disorder and another 20% experiences occasional Insomnia symptoms. Women, older adults, and people with socioeconomic hardship are more vulnerable to Insomnia. Insomnia is often a chronic condition, with a 40% persistence rate over a 5 year period. Insomnia is a significant public health problem that should be addressed at the individual level with appropriate clinical care. Primary Insomnia is a sleep disturbance that cannot be attributed to medical, psychiatric, or environmental cause. On the other-hand secondary Insomnia caused by an underlying medical condition or a medication. Hypnotic medications like benzodiazepines and non-benzodiazepines are often used for treatment but carry risks, including an increased risk of Dementia.  Shiroabyanga is a form of Bahirparimarjana Chikitsa and are also a part of Dinacharya, is told to be beneficial in inducing Nidra. Hence the same has been employed in the present study. Charaka Samhita mentioned that Shiroabyanga helps to promote Nidra, prevents headache, greying, hair fall and it also gives strength to skull, strengthens hair root. It also nourishes the sense organs, softens the skin and one gets good sleep after *Shiroabyanga.*Medical Acupuncture is a system which can influence three areas of healthcare – promotion of health and wellbeing, prevention of illness, treatment of various medical conditions.The World Health Organization (WHO) recognize the use of acupuncture in the treatment of wide range of medical problems including digestive disorders, respiratory disorders, neurological disorders, muscular disorders, urinary, menstrual and reproductive problems. Acupuncture mainly has six effects i.e, analgesic effect, sedation effect, homeostatic or regulatory effect, immune-enhancing action, psychological effect, which is calming and tranquilizing action apart from mere sedation. It also helps in motor recovery in patients who have become paralyse. Needling of certain specific Acupuncture points results sedation. Some people may even fall asleep during treatment, but wakeup refreshed, it has been shown that there is a decrease in delta and theta wave activity on the electro-encephalogram during Acupuncture treatment. These effects utilised in the Acupuncture treatment for Insomnia, Anxiety states, addictions, Epilepsy, mental disorders and behavioural problems.

Hence this study is taken up to evaluate the effect of Acupuncture in Anidra w.s.r. to Primary Insomnia.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Subject of age group between 21-60 years, irrespective of gender, religion, occupation, and socioeconomic status will be selected.
  • 2.Subjects with classical signs and symptoms of Anidra and Primary Insomnia.
  • 3.Subjects willing to give informed consent.
  • 4.Subjects fit for Acupuncture and Shiroabyanga.

排除标准

  • 1.Subjects who have underwent treatment for Insomnia in the past 2 weeks.
  • 2.Subjects who have been diagnosed with the psychiatric disorder or a history of major neuropsychiatric disorder.
  • (for example autism, learning disorder, mental retardation and so on) 3.Subjects who have infection or inflammation at the acupoints.
  • 4.Subjects diagnosed with hemorrhagic disease or anticoagulant intake.
  • 5.Pregnancy and lactating mothers.

结局指标

主要结局

Significant improvement in quality of sleep based on Brief Psychiatric Rating Scale and PSQI Score.

时间窗: Pre-Study Assessment - 0th Day | 1st Assessment - 7th day | Follow up - 14th Day

次要结局

  • 1.Generation of in depth analysed data on different aspect of disease and its treatment.(2.Generation of data on possible unexpected reaction.)

研究者

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

Dr Vinod

Sri Sri College of Ayurvedic Science and Research Hospital

研究点 (1)

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