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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (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: - | 2 | Intervention Arm | Drug | Classical | | (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 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. |