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CTRI Number  CTRI/2024/08/072471 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to Evaluate the Effectiveness of Sublingual Jatamansi Churna and Mahish Ghrit Padabhyanga in Insomnia. 
Scientific Title of Study   To evaluate the combined efficacy of Jatamansi Churna sublingually along with Mahish Ghrit Padabhyanga in the management of Anidra w.s.r. to insomnia - an open labelled single arm clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bansari M Kalsariya 
Designation  PG Scholar  
Affiliation  Shree Swaminarayan Ayurvedic College, Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, AT&PO, Saij, Ta. Kalol, Dist. Gandhinagar - 382725

Gandhinagar
GUJARAT
382725
India 
Phone  9426689906  
Fax    
Email  vd.bmkalsariya25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd Tapankumar M 
Designation  Professor 
Affiliation  Shree Swaminarayan Ayurvedic College, Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, AT&PO, Saij, Ta. Kalol, Dist. Gandhinagar - 382725

Gandhinagar
GUJARAT
382725
India 
Phone  9924304388  
Fax    
Email  vdtapankumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishal Solanki 
Designation  Associate Professor  
Affiliation  Shree Swaminarayan Ayurvedic College, Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, AT&PO, Saij, Ta. Kalol, Dist. Gandhinagar - 382725

Gandhinagar
GUJARAT
382725
India 
Phone  9558121886  
Fax    
Email  vishal12solanki@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital, Ahmedabad-Mehsana Highway, AT&PO. Saij, Ta. Kalol, Dist. Gandhinagar- 382725 
 
Primary Sponsor  
Name  Shree Swaminarayan Ayurvedic College  
Address  Faculty of Ayurved, Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, AT&PO. Saij, Ta. Kalol, Dist. Gandhinagar- 382725 
Type of Sponsor  Private medical college 
 
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 
Dr Bansari M Kalsariya  Premswarup Swami Ayurvedic Multispecialty Hospital   OPD 004, Department of Kayachikitsa, Premswarup Swami Ayurvedic Multispeciality Hospital, Ahmedabad-Mehsana Highway, At.&Po. Saij, Ta. Kalol, Dist. Gandhinagar - 382725
Gandhinagar
GUJARAT 		 9426689906

vd.bmkalsariya25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Shree Swaminarayan Ayurvedic College and Hospital, Kalol  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-EkA~gga, एकांग  (Procedure Reference: Su.Chi.24/70-71, Procedure details: First, clean both legs and feet with lukewarm water and wipe up. Do gentle massage on each foot for 3-4 min by hand at night. Do rest for 10 mins. Excessive Ghrit will be wiped up with a cloth.)
(1) Medicine Name: Mahish Ghrit, Reference: Su.Su.45/99, Route: Topical, Dosage Form: Ghrita, Dose: 40(ml), Frequency: hs, Duration: 30 Days
2Intervention ArmDrugClassical(1) Medicine Name: Jatamansi, Reference: Priya Nighantu, Shatpushpadi Varga 36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 300(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Jatamansi churna should be taken sublingually.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient with 3 or more symptoms of Anidra (primary insomnia).
2. Difficulty in initiating sleep.
3. Difficulty in maintaining sleep.
4. Primary insomnia such as insomnia without identifiable cause.
5. Recent changes in sleep pattern
6. Anidra with a history of a minimum of 2 week.
7. Insomnia Severity Index above a score of 7.  
 
ExclusionCriteria 
Details  1. K/C/O major psychiatric illness, chronic disease, and acute condition were excluded from the study.
2. Patients suffering from other systemic illnesses like CNS etc.
3. Chronic alcohol and caffeine users and drug dependents were also excluded from the study to achieve better results.
4. Patients who have night shift work schedules.
5. Drug-induced insomnia.
6. Pregnant or lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of the combined efficacy of Jatamansi Churna sublingually along with Mahish Ghrit Padabhyanga in the management of Anidra (Insomnia).  Baseline, Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
1. Understanding the pathophysiology of Anidra from both Ayurvedic and modern perspectives.
2. Evaluating changes in subjective sleep quality. 		 Baseline, Day 30 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/10/2024 
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="0"
Months="11"
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   Anidra, or insomnia, is recognized as a disorder in Ayurvedic texts, associated with imbalances in bodily and mental doshas. Despite Ayurveda’s traditional use in treating insomnia, scientific validation of its efficacy is lacking, especially concerning specific treatments like Jatamansi churna and Mahish ghrit padabhyanga. This study seeks to bridge this gap by exploring the scientific basis of Ayurvedic interventions for insomnia. The study involves 40 individuals diagnosed with insomnia, who will receive Jatamansi churna and Mahish Ghrit Padabhyanga for a duration of 30 days. The study will monitor changes in their symptoms throughout the treatment period. Modern medicine often relies on medications like benzodiazepines for insomnia, which can have adverse effects and dependency issues. By investigating Ayurvedic approaches, this study aims to provide evidence for their effectiveness and promote their wider adoption. The research will focus on previously unexplored areas, including the sublingual route of administration and the combined efficacy of Jatamansi churna and Mahish ghrit padabhyanga. By shedding light on these aspects, the study aims to enhance understanding and acceptance of Ayurvedic practices in addressing insomnia, ultimately contributing to improved healthcare options and quality of life. 
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