| CTRI Number |
CTRI/2025/09/094617 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of medical students in supporting stable hypertensive patients by giving reminders for medication adherence and life style modification and measuring the change in Blood pressure after 8 weeks. |
|
Scientific Title of Study
|
Role of medical student emphasizing non pharmacological management of hypertension and medication adherence in stable hypertensive patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Chaturvedi |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chamba |
| Address |
Pandit Jawahar Lal Nehru Government Medical College ,near
Akhand Chandi Palace Chamba Himachal Pradesh ,India
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9410507009 |
| Fax |
|
| Email |
aditichaturvedi1978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Chaturvedi |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chamba |
| Address |
Pandit Jawahar Lal Nehru Government Medical College ,near
Akhand Chandi Palace Chamba Himachal Pradesh ,India
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9410507009 |
| Fax |
|
| Email |
aditichaturvedi1978@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Chaturvedi |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chamba |
| Address |
Pandit Jawahar Lal Nehru Government Medical College ,near
Akhand Chandi Palace Chamba Himachal Pradesh ,India
Chamba
HIMACHAL PRADESH
176310
India |
| Phone |
9410507009 |
| Fax |
|
| Email |
aditichaturvedi1978@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aditi Chaturvedi |
| Address |
Pharmacology Department Pandit Jawahar Lal Nehru Chamba pin 176310 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Umer Jalalie |
Government Medical College and Hospital Chamba |
Medicine Department OPD Number 213 Pandit Jawahar Lal Nehru Government Medical College
Chamba Himachal Pradesh ,India
Chamba
HIMACHAL PRADESH |
09410507009
jalalieumer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC CHAMBA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary Modifications for 8 weeks |
1.Salt restriction
2.DASH Diet plan |
| Intervention |
Exercise for 8 weeks |
Daily exercise for 20 minutes |
| Intervention |
Lifestyle modifications for 8 weeks |
1.Avoid smoking and alochol intake.
2.Regular BP mointoring of patients |
| Intervention |
Mediation for 8 weeks |
1.Daily mediation for 10 minutes
2.Sharing video of yoga nidra |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Hypertensive for 6 months.
2.Age group between 30-50 years.
3.No other organ involvement or comorbidities.
4.On fixed dose of one antihypertensive medication for atleast 6 months.
5.Person enrolled should have digital BP monitoring device at home. |
|
| ExclusionCriteria |
| Details |
1.Taking more than one antihypertensive medication.
2.Newly diagnosed hypertensive.
3.Age more than 50 years or less than 30 years.
4.Having complications like heart disease/kidney disease/stroke/retinopathy.
5.Person not having digital BP mointoring device at their home |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mean reduction in blood pressure of hypertensive patients in two months in the control group and students intervention group. |
At the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the adherence to non -pharmacological & pharmacological treatment in the control group & student intervention group using Moriskys adherence questionnaire MMAS-4
2.To elicit patient feedback in the control & student intervention group. |
At the end of 8 weeks |
|
|
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)
|
24/09/2025 |
| 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="2"
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).
- For how long will this data be available start date provided 12-12-2025 and end date provided 15-05-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The project will investigate how lifestyle modification can help patients manage their blood pressure. Investigator having patients, will assess their blood pressure after a duration of time before and after non pharmacological approach. Participants will ask their patient lower their sodium intake ,do exercise , meditation and also stop smoking and adherent to pharmacological treatment with regular monitoring of blood pressure. |