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CTRI Number  CTRI/2025/03/083003 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Evaluation of Physiological effect of Bhramari Pranayama on Nidranasha. 
Scientific Title of Study   A Clinical Study to Evaluate Physiological effects of Bhramari Pranayama in Nidranasha 
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 Nisha Amale 
Designation  P G Scholar 
Affiliation  D.Y. Patil University, School of Ayurveda, Nerul, Navi Mumbai 
Address  D.Y.Patil University, School Of Ayurveda, Department of Kriya Sharir, 2 nd Floor, Sector7, Nerul east Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09870831570  
Fax    
Email  nisha.borhade86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shruti Phatak 
Designation  Reader 
Affiliation  D.Y. Patil University, School of Ayurveda, Nerul, Navi Mumbai 
Address  D.Y. Patil University, School of Ayurveda, Department of Kriya Sharir, 2nd Floor, Sector 7, Nerul east, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09870831570  
Fax    
Email  shruti.phatak@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Nisha Amale 
Designation  P G Scholar 
Affiliation  D.Y. Patil University, School of Ayurveda, Nerul, Navi Mumbai 
Address  D.Y.patil University, School Of Ayurveda, Department of Kriya Sharir, 2 nd Floor, Sector 7, Nerul east, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  09870831570  
Fax    
Email  nisha.borhade86@gmail.com  
 
Source of Monetary or Material Support  
D.Y.Patil Univesity, School of Ayurveda, Nerul, Navi Mumbai 400706 
 
Primary Sponsor  
Name  Dr Nisha Amale 
Address  P.G. Scholar, 2 nd Floor, Department of Kriya Sharir, School of Ayurveda, D.Y. Patil University, Sector7, Nerul East Navi Mumbai 
Type of Sponsor  Other [Self] 
 
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 Nisha Rupesh Amale  D.Y.Patil University School Of Ayurveda  Deparment of Kriya Sharir, 2 nd Floor, Sector 7, Nerul East, Navi Mumbai
Thane
MAHARASHTRA 		 9870831570

nisha.borhade86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Member,Institutional Ethics Committee, D.Y.Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai  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 ArmLifestyle--Dinacarya: 3 sets of Bhramari Pranayama, Each set consist of 5 Cycles. Total 15 cycles. Total Duration is of 3 Months, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients presenting with Lakshana Of Nidranasha. Subject ready to abide by trial procedure and to give informed consent 
 
ExclusionCriteria 
Details  Patient below 25 years and above 45 years of age. Patinets who are unfit for Bhramari Pranayama according to ayurveda classics. patients who are suffering from other sysytemic diseases which interferes with the couse of treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Sleep quality, Sleeplessness, Sleep Time, Sleep Wake Schedule, After Awakening  Baseline, after 4 Weeks,8 Weeks and 12 Weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Serum Cortisol levels.  baseline, After 12 Weeks. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   25/03/2025 
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="3"
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  

This study aims to evaluate the impact of Bhramari Pranayama, a traditional yogic breathing technique, on Nidranasha, which refers to sleep disturbances or insomnia. In Ayurvedic medicine, proper sleep is essential for overall health and well-being, and Nidranasha is often linked to imbalances in the body’s doshas. The research investigates whether practicing Bhramari Pranayama can help restore balance and improve sleep quality. Participants will be assessed before and after a period of practicing Bhramari Pranayama, with a focus on changes in sleep patterns, duration, and quality. The study also seeks to understand the physiological and psychological mechanisms through which Bhramari Pranayama may alleviate symptoms of Nidranasha. The findings could potentially support the inclusion of this pranayama technique as an effective non-pharmacological intervention for managing sleep-related issues.

 
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