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CTRI Number  CTRI/2025/01/079231 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find the effective Pranayam between Nadi Shuddhi Pranayam and Bhramari pranayam in the management of high blood pressure. 
Scientific Title of Study   Randomised comparative open clinical study between nadi shuddhi pranayam and bhramari pranayam in the management of hypertension. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Rahim Jamadar  
Designation  MD Scholar  
Affiliation  Yashwant Ayurvedic College, Post-Graduate Training and research center, Kodoli. 
Address  Swastharakshan OPD, Swasthavritta department, Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.)

Kolhapur
MAHARASHTRA
416114
India 
Phone  8421197192  
Fax    
Email  rahimrj123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Milind Mohan Godbole  
Designation  Professor Swasthvritta Department  
Affiliation  Yashwant Ayurvedic College, Post-Graduate Training and research center, Kodoli. 
Address  Swastharakshan OPD, Swasthavritta department, Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.)

Kolhapur
MAHARASHTRA
416114
India 
Phone  9850119900  
Fax    
Email  drmilindgodbole@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Rahim Jamadar  
Designation  MD Scholar  
Affiliation  Yashwant Ayurvedic College, Post-Graduate Training and research center, Kodoli. 
Address  Swastharakshan OPD, Swasthavritta department, Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.)

Kolhapur
MAHARASHTRA
416114
India 
Phone  8421197192  
Fax    
Email  rahimrj123@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.) 
 
Primary Sponsor  
Name  Vd. Rahim Jamadar  
Address  Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.) 
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 
Vd Rahim Jamadar   Yashwant dharmarth rugnalaya, Kodoli  Swastharakshan OPD, Swasthavritta department, Yashwant Ayurvedic College, Post-Graduate Training and research center, A/p- Kodoli, Tal-Panhala, Dist-Kolhapur. 416114 (M.S.)
Kolhapur
MAHARASHTRA 		 8421197192

rahimrj123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yashwant Ayurvedic College Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: SIRAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Nadi shuddhi Pranayama, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Bhramari pranayama, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Subjects suffering from primary Grade 1 and Grade 2 hypertension i.e. systolic blood pressure 140-179 mm of hg and/or diastolic blood pressure 90-109 mm of hg. ( NHM, ministry of health and family welfare, government of India guideline 2016).
2) Subjects on their antihypertensive therapy.
3) Subjects willing to provide informed consent. 
 
ExclusionCriteria 
Details  1) Patients with secondary hypertension.
2) History of COPD or allergic asthma.
3) Patients with the history of MI, unstable angina, arrhythmias, CCF, stroke, uncontrolled endocrine or metabolic diseases, hepatic failure, impaired renal function, severe or uncontrolled diabetes mellitus, tuberculosis, malignancy, patients who are operated for any reason.
4) Pregnant women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of nadi shuddhi pranayam and bhramari pranayam in the management of hypertension.  60 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To study effect of nadi shuddhi pranayam in the management of hypertension   60 days. 
To study effect of bhramari pranayam in the management of hypertension   60 days. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rahimrj123@gmail.com].

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Hypertension is the most prevalent non communicable disorder affecting the major population of India and it is huge health challenge in 21st century. Previous studies on pranayama and hypertension showed a reduction of heart rate, blood pressure and improvement of cardiorespiratory parameters. So this study is designed to compare effect of Nadi Shuddhi Pranayam and Bhramari Pranayam in the management of Hypertension. This research work will help doctors, yoga practitioner and yoga teachers to advice Pranayam to Hypertensive patients in better way as supportive as well as first line of treatment. Patients were taken for study and divided in to two groups for Nadi Shuddhi Pranayam and Bhramari Pranayam and were advised to do their respective Pranayam for two months in which 15 days interval follow up will be taken. Before and after treatment assessment will be done with the help of Assessment criteria. 
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