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CTRI Number  CTRI/2025/12/099637 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Guided Meditation for Better Health in Hypertension  
Scientific Title of Study   Effect of Guided Meditation on Spiritual Wellbeing and Quality of Life in Hypertensive Patients:A Randomized Control 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 Bhalendu Vaishnav 
Designation  Professor and Head, Department of Medicine, 
Affiliation  Pramukhswami Medical College, Bhaikaka University 
Address  OPD 108 Shree Krishna Hospital and Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat

Anand
GUJARAT
388325
India 
Phone  9825717481  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhalendu Vaishnav 
Designation  Professor and Head, Department of Medicine, 
Affiliation  Pramukhswami Medical College, Bhaikaka University 
Address  OPD 108 Shree Krishna Hospital and Pramukhswami Medical College, Bhaikaka University Karamsad, Gujarat

Anand
GUJARAT
388325
India 
Phone  9825717481  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Mansi Modi 
Designation  Postgraduate student Department of Medicine, 
Affiliation  Pramukhswami Medical College, Bhaikaka University 
Address  OPD Number 108, Department of Medicine, Shree Krishna Hospital

Anand
GUJARAT
388325
India 
Phone  09427188500  
Fax    
Email  mansidm@bhaikakauniv.edu.in  
 
Source of Monetary or Material Support  
Pramukhswami medical college, BHaikaka University, Karamsad, Gujarat, India. PIN 388325 Gujarat 
 
Primary Sponsor  
Name  Dr Bhalendu Suryakant Vaishnav 
Address  Department of Medicine, Pramukhswami Medical College, Bhaikaka University Karamsad, GUjarat, India PIN 388325  
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 Bhalendu Vaishnav  OPD 108, Shree Krishna Hospital  OPD 108, Shree Krishna Hospital, and Pramukhswami Medical College, Karamsad, Gujarat, India.
Anand
GUJARAT 		 09825717481

bhalendusv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2, Bhaikaka University, Karamsad, Anand, Gujarat  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guided Meditation  Guided Meditation daily for 15 minutes for 6 weeks with help of an audio device • Control group: Standard quality Care • Clinical and biochemical evaluation will be done before commencement of intervention. (Any Lab evaluation within past 6 months will be accepted as baseline) • Participants will be asked to maintain a diary / fill up subjective experiences related to listening GM on Google form daily. Duration of intervention: 6 weeks  
Comparator Agent  NIL  Control group will receive standard care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients of essential hypertension between 18.00 and 70.00 form eligibility criteria 
 
ExclusionCriteria 
Details  1. Cardiac failure, Renal failure, Symptomatic IHD/Previous history of IHD
2. Acute or chronic illness: Febrile illness, COPD, CLD, C V Stroke, Hypo/ hyperthyroidism 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Blood pressure and Spiritual Wellbeing
 		 After 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of Life and Sleep as a result of GM  After 6 weeks 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   07/01/2026 
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhalendusv@charutarhealth.org].

  6. For how long will this data be available start date provided 03-01-2027 and end date provided 03-01-2029?
    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   This study is designed to assess effects of guided meditation delivered through an audio device on OPD basis on quality of life, psychological general wellbeing, and quality of sleep and Spiritual Wellbeing in hypertensive patients.  
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