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CTRI Number  CTRI/2023/08/056999 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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) 
Scientific Title of Study   An observational study on Nidra (sleep quality) and cognitive performance in different Deha prakriti and effect of Bilva Khala on Anidra (Primary insomnia) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suvitha S V 
Designation  Ph.D scholar 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  6th floor, Department of Kriya Sharir, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7502974362  
Fax    
Email  svsuvitha92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khandale 
Designation  Assistant Professor  
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  6th floor, Department of Kriya Sharir, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9850483223  
Fax    
Email  khandale_swati@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khandale 
Designation  Assistant Professor  
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  6th floor, Department of Kriya Sharir, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9850483223  
Fax    
Email  khandale_swati@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Institute of Teaching and Research in Ayurveda,Opp B division police station, Gurudwara road,Jamnagar, Gujarat, India, 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Suvitha S V  Institute of Teaching and Research in Ayurveda, JAMNAGAR  OPD no18, Department of Kriya Sharir, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, 361008
Jamnagar
GUJARAT 
07502974362

svsuvitha92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F510||Insomnia not due to a substance orknown physiological condition. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Pippali Moola Choorna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Jaggery), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Bilva Khala, Reference: Cikitsa Manj ari-Mandanidra Cikitsa, Route: Oral, Dosage Form: Pramathya, Dose: 50(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: Khala is a Pathya Kalpana which is similar to Pramathya kalpana. In Khala preparation, takra will be used in place of drava dravya. Ratio of drug and takra will be 1:16 and it should be reduced to 1/4
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.

Changes in the clinical symptoms of Anidra 0th & 42nd day. 
6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
 Improvement in cognitive performance & stress & anxiety level by assessing the changes noted in scoring pattern of concerned scale 0th and 42nd day.  6 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 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 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.


 
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