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临床试验/CTRI/2023/08/056999
CTRI/2023/08/056999尚未招募2/3 期

An observational study on Nidra (sleep quality) and cognitive performance in different Deha prakriti and effect of Bilva Khala on Anidra (Primary insomnia)

Institute of Teaching and Research in Ayurveda, Jamnagar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Changes in the clinical symptoms of Anidra 0th & 42nd day.

研究概览

简要总结

Introduction:Sleep is an essential part of life. Physical development, emotional control, cognitive function, and quality of life are all significantly impacted by sleep, which is a crucial element of health and wellbeing. In Ayurveda, Nidra is considered as one of the TrayoupasthambaSamyak and Asamyak Nidra is responsible for Gyana and Agyana respectively*.*  Sleep pattern of every subject will depend on their Prakriti. Studies that examine the effects of sleep deprivation have noted drastic deficits in cognitive processing. The word cognition refers ‘to know’ or perceiving knowledge.When comes to learning and memory capacity, Vata Prakriti are considered as Shruta Grahi and Alpha Smriti i.e., quick to understand but forgets easily and Kapha Prakriti will have the quality of vise-versa. Population-based estimates indicate that about one-third of adults report insomnia symptoms, 10%-15% experience associated daytime impairments, and 6% -10% have symptoms that meet criteria for insomnia disorder.So, the present study will be conducted in two phases. On the first phase, an observational study will be conducted to find out the relation of sleep quality and cognitive performance in different Deha Prakriti. On the second phase, clinical trial will be conducted to evaluate the efficacy of Bilva Khala on primary insomnia.

Materials and Methods:

Detailed review of literature will be  carried out. Microbiological study for Bilva Churnawill be         carried out to rule out any microbial contamination at the regular time interval of 1 month till completion of the study. Detailed pharmacognostical and pharmaceutical study of Bilva Churna will be done. In analytical study, the preliminary physico-chemical and phytochemical characters of Bilva Churna

Observational study(cross sectional)

In the first phase, to find out the association of Nidra and cognitive performance in different Deha Prakriti, a cross-sectional study will be conducted with sample size 200. Study population will be general population of Jamnagar which will be screened out using convenience sampling method.

Clinical study

In the second phase, 60 patients having signs and symptoms of Anidra (Primary insomnia) will be randomly enrolled into two groups. Patients who have primary insomnia and fits into selection criteria will be selected In experimental group-subjects are advised to follow sleep hygiene along oral administration of Bilva as Khala preparation form for 6 weeks. In Control group – subjects are advised to follow sleep hygiene along with and Pippali Moola Churna along with jaggery. The patients will be assessed based on subjective and objective parameters on 0th and 42nd day.

 Results: Data generated during the above study will be presented in a systematic manner and shall be analyzed statistically. Suitable statistical tests i.e., Chi square and Odds ratio test and co – efficient of correlation will be applies to the data so as to find out the relation of Nidra and cognitive performance in different Deha Prakriti.

Assessment will be done on the basis of special proforma through scoring pattern and will be analyzed statistically with help of Friedman test in subjective parameters, Wilcoxon statistical tool will be used to assess the impact on objective parameters and paired’ test will be used. >0.05 = insignificant result and <0.05=significant result.

 Discussion and conclusion: The analysed data will be presented in a summarized form and appropriate 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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Primary Insomnia like Insomnia without Identifiable Cause and Psycho-physiologic Insomnia having score more than
  • Fresh patients of Insomnia who are not addicted to drugs will be included.
  • Insomnia cases not less than one month will be included.

排除标准

  • Patients suffering from chronic Insomnia who were addicted to sedative medications and taking any drugs possessing sedative effect will be excluded.
  • Secondary Insomnia like Transient Situational Insomnia, Insomnia Associated with Neurological Disorders, Mental Disorders, Drug or Alcohol-Dependent Insomnia Known case of chronic illness and other hormonal diseases Recently done surgery Pregnant ladies and lactating mother.

结局指标

主要结局

Changes in the clinical symptoms of Anidra 0th &amp; 42nd day.

时间窗: 6 weeks

Improvement in condition will be assessed on the basis of changes in scoring patterns of Insomnia severity index &amp; Athens insomnia scale on 0th &amp; 42nd day.

时间窗: 6 weeks

次要结局

  • Improvement in cognitive performance & stress & anxiety level by assessing the changes noted in scoring pattern of concerned scale 0th and 42nd day.(6 weeks)

研究者

发起方
Institute of Teaching and Research in Ayurveda, Jamnagar
申办方类型
Research institution and hospital

研究点 (1)

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