| CTRI Number |
CTRI/2026/03/106169 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study is being done to see if Marma Chikitsa, an Ayurvedic therapy that works on certain important points of the body, can help lower blood pressure when used together with the regular medicines taken by people who have long-term high blood pressure. |
|
Scientific Title of Study
|
Evaluation of the Add-on Effect of Marma Chikitsa on Talahridaya Marma Along With Standard Antihypertensive Drugs on Blood Pressure in Chronic Hypertensive Patients : 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 Shubham Zodpe |
| Designation |
MD Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Pakwasa Samanvaya Rugnalaya Nagpur |
| Address |
Rachana Sharir Department, Pakwasa Samanvaya Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, 440024, Nagpur, Maharashtra, India.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9767782044 |
| Fax |
|
| Email |
zodpeshubham01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Choudhari |
| Designation |
Professor & Head of Department |
| Affiliation |
Shri Ayurved Mahavidyalaya Pakwasa Samanvaya Rugnalaya Nagpur |
| Address |
Rachana Sharir Department, Pakwasa Samanvaya Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, 440024, Nagpur, Maharashtra, India.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8856018808 |
| Fax |
|
| Email |
vmchoudhari72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Zodpe |
| Designation |
MD Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Pakwasa Samanvaya Rugnalaya Nagpur |
| Address |
Rachana Sharir Department, Pakwasa Samanvaya Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, 440024, Nagpur, Maharashtra, India.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9767782044 |
| Fax |
|
| Email |
zodpeshubham01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pakwasa Samanvaya Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, 440024, Nagpur, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Sanjay Zodpe |
| Address |
Rachana Sharir Department, Pakwasa Samanvaya Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar, 440024, Nagpur, Maharashtra, India. |
| 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 Vinod Choudhari |
OPD & IPD of Departments of Panchakarma and Kayachikitsa, Pakwasa Samanvay Rugnalaya, Nagpur |
Hanuman Nagar, Nagpur 440024
Maharashtra India
Nagpur
MAHARASHTRA |
8856018808
vmchoudhari72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Shri Ayurved Mahavidyalya ,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Antihypertensive drugs only | Chronic hypertensive patients receiving standard Anti Hypertensive medications | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा, with Antihypertensive drugs | (Procedure Reference: Published article, Procedure details: standard Antihypertensive drugs along with Marma chikitsa for 3 Minutes each day for 10 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pre_diagnosed patients, SBP more than 139, DBP more than 89 |
|
| ExclusionCriteria |
| Details |
Taking immunosuppressant, Taking oral contraceptives, Pregnancy associated hypertension |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic and diastolic blood pressure from baseline to day 10 |
day 2 to day 10 and day 15th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in hypertension related symptoms like Headache, Dizziness, Palpitations, Fatigue, Sleep disturbances assessed using Visual Analogue Scale. |
day 2 to day 10 and day 15th |
| Change in Pulse rate |
day 2 to day 10 and day 15th |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
25/03/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
This study is a prospective, randomized, double-blind, parallel-group clinical trial designed to evaluate the add-on effect of Talahridaya Marma Chikitsa along with standard antihypertensive drugs in patients with chronic hypertension. A total of 84 participants will be randomly allocated into intervention and control groups. The intervention group will receive Marma Chikitsa once daily for 10 days in addition to standard antihypertensive treatment, while the control group will receive standard treatment alone. Primary outcomes include changes in systolic and diastolic blood pressure, while secondary outcomes include pulse rate and symptom assessment using Visual Analog Scale. |