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CTRI Number  CTRI/2024/12/078788 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing morning and evening timing of blood pressure medicines, with and without daily WhatsApp reminders 
Scientific Title of Study   Effectiveness of morning versus evening dosing of antihypertensive medications with and without daily mobile reminders: 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 Harshad Venugopal Ramineni 
Designation  Postgraduate Student in Pharmacology 
Affiliation  Karnataka Medical College and Research Institute, Hubballi 
Address  Room number 1, First Floor, College Building, Department of Pharmacology, Karnataka Medical College and Research Institute, Vidyanagar, Hubballi, Karnataka - 580021.

Dharwad
KARNATAKA
580021
India 
Phone  9664803317  
Fax    
Email  harshadramineni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A N Dattatri 
Designation  Professor and Head 
Affiliation  Karnataka Medical College and Research Institute, Hubballi 
Address  Room number 1, First Floor, College Building, Department of Pharmacology, Karnataka Medical College and Research Institute, Vidyanagar, Hubballi, Karnataka - 580021.

Dharwad
KARNATAKA
580021
India 
Phone  9902354622  
Fax    
Email  dattatri69@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A N Dattatri 
Designation  Professor and Head 
Affiliation  Karnataka Medical College and Research Institute, Hubballi 
Address  Room number 1, First Floor, College Building, Department of Pharmacology, Karnataka Medical College and Research Institute, Vidyanagar, Hubballi, Karnataka - 580021.

Dharwad
KARNATAKA
580021
India 
Phone  9902354622  
Fax    
Email  dattatri69@gmail.com  
 
Source of Monetary or Material Support  
Karnataka Medical College and Research Institute, Vidyanagar, Hubballi, Karnataka - 580021, India. 
 
Primary Sponsor  
Name  Dr Harshad Venugopal Ramineni 
Address  Room number 1, First Floor, College Building, Department of Pharmacology, Karnataka Institute of Medical Sciences, Vidyanagar, Hubli, Karnataka - 580021. 
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 Ram S Kaulgud  Karnataka Medical College and Research Institute Hubballi  Room No 40, Medical OPD, Ground Floor, OPD Block, Karnataka Institute of Medical Sciences, Vidyanagar, Hubli, Karnataka - 580021.
Dharwad
KARNATAKA 		 9844426887

drkaulgud.kims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Karnataka Medical College and Research Institute Hubballi  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  Evening dosing with daily mobile reminders  Antihypertensive medication administered in the evening at 8:00 PM with daily mobile reminders to improve medication adherence, for a duration of 8 weeks. 
Comparator Agent  Evening dosing without WhatsApp reminder  Antihypertensive medication administered in the evening at 8:00 PM without daily mobile reminders, for a duration of 8 weeks. 
Intervention  Morning dosing with daily mobile reminders  Antihypertensive medication administered in the morning at 8:00 AM with daily mobile reminders to improve medication adherence, for a duration of 8 weeks. 
Comparator Agent  Morning dosing without mobile reminders  Antihypertensive medication administered in the morning at 8:00 AM without daily mobile reminders, for a duration of 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adults aged 18–65 years with a diagnosis of essential hypertension.
2. On stable once-daily antihypertensive therapy for at least 4 weeks.
3. Access to a smartphone with WhatsApp installed.
4. Giving written consent for participating in the trial. 
 
ExclusionCriteria 
Details  1. Secondary hypertension or hypertensive emergencies.
2. Comorbid conditions requiring complex drug regimens.
3. Non-compliance or inability to adhere to the protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean reduction in systolic and diastolic blood pressure (measured in mmHg).  Baseline, 4 weeks, and 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Adherence to antihypertensive medication (measured using a validated scale like MMAS-8).  Baseline, 4 weeks, and 8 weeks. 
Participant satisfaction with the intervention (measured using a satisfaction survey or questionnaire).  At the 8-week follow-up. 
Incidence of adverse effects related to antihypertensive medications (e.g., dizziness, fatigue).  Monitored throughout the 8-week trial period. 
 
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 4 
Date of First Enrollment (India)   06/01/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
    Response -  Analytic Code

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 20-06-2025 and end date provided 20-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   "MEANDER" is a prospective, randomized, open-label, controlled trial aiming to compare the effectiveness of morning versus evening dosing of antihypertensive medications on blood pressure control. The study also evaluates the role of WhatsApp medication reminders in improving adherence and assesses the combined effect of dosing time and reminders on patient satisfaction and blood pressure outcomes. Conducted over 8 weeks at Karnataka Medical College and Research Institute, Hubballi, this trial includes four groups with different combinations of dosing times and reminders, focusing on adults aged 18–65 with essential hypertension. 
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