An Observational study to assess sleep quality and cognitive performance in different Deha Prakriti and a clinical trial to evaluate the effect of Bilva Khala on loss of sleep (Anidra)
- Conditions
- Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,
- Registration Number
- CTRI/2023/08/056999
- Lead Sponsor
- Institute of Teaching and Research in Ayurveda, Jamnagar
- Brief Summary
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 *Trayoupasthamba*. *Samyak 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 Churna*will 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Primary Insomnia like Insomnia without Identifiable Cause and Psycho-physiologic Insomnia having score more than 6.
- Fresh patients of Insomnia who are not addicted to drugs will be included.
- Insomnia cases not less than one month will be included.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the clinical symptoms of Anidra 0th & 42nd day. 6 weeks Improvement in condition will be assessed on the basis of changes in scoring patterns of Insomnia severity index & Athens insomnia scale on 0th & 42nd day. 6 weeks
- Secondary Outcome Measures
Name Time Method Improvement in cognitive performance & stress & anxiety level by assessing the changes noted in scoring pattern of concerned scale 0th and 42nd day. 6 weeks
Trial Locations
- Locations (1)
Institute of Teaching and Research in Ayurveda, JAMNAGAR
🇮🇳Jamnagar, GUJARAT, India
Institute of Teaching and Research in Ayurveda, JAMNAGAR🇮🇳Jamnagar, GUJARAT, IndiaSuvitha S VPrincipal investigator07502974362svsuvitha92@gmail.com