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CTRI Number  CTRI/2025/07/091658 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Health Intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Awareness of the health intervention in hypertension control.  
Scientific Title of Study   A Pilot study on the impact of an educational health intervention in hypertension control in Angara block , Jharkhand: A Randomized Controlled 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 Shashi Bhushan Singh 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of community Medicine,Rajendra Institute of Medical Sciences, Ranchi
Bariatu
Ranchi
JHARKHAND
834009
India 
Phone  7717791865  
Fax    
Email  sbsingh2011@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Bhushan Singh 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of community Medicine,Rajendra Institute of Medical Sciences, Ranchi
Bariatu
Ranchi
JHARKHAND
834009
India 
Phone  7717791865  
Fax    
Email  sbsingh2011@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashi Bhushan Singh 
Designation  Additional Professor 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of community Medicine,Rajendra Institute of Medical Sciences, Ranchi
Bariatu
Ranchi
JHARKHAND
834009
India 
Phone  7717791865  
Fax    
Email  sbsingh2011@yahoo.com  
 
Source of Monetary or Material Support  
MRHRU 
 
Primary Sponsor  
Name  MRHRU Angara 
Address  Model Rural Health Research Unit Angara, Ranchi Jharkhand 835103 
Type of Sponsor  Government funding agency 
 
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 Shashi Bhushan Singh  MRHRU  MRHRU, Angara, Ranchi Jharkhand - 835103
Ranchi
JHARKHAND 		 07717791865

sbsingh2011@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RIMS RANCHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D759||Disease of blood and blood-formingorgans, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational health interventions  Structured educational sessions focusing on hypertension management 
Comparator Agent  Standard care  standard care 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Participants must be adults aged more than 30 and diagnosed with hypertension. Also they should be residents of Angara block for at least on year. 
 
ExclusionCriteria 
Details  Participants with severe hypertension . Pregnant women are not include in the study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
improved blood pressure control  six months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL 
 
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 3 
Date of First Enrollment (India)   11/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sbsingh2011@yahoo.com].

  6. For how long will this data be available start date provided 15-07-2026 and end date provided 15-07-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This pilot study introduces a novel educational health intervention tailored to the needs of individuals with hypertension in Jharkhand. It employs a pilot randomized controlled trial methodology, focusing on the Angara block of Ranchi, Jharkhand as the study site.  
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