| CTRI Number |
CTRI/2023/02/049554 [Registered on: 08/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Marma Chikitsa in Blood Pressure |
|
Scientific Title of Study
|
Anatomico Clinical Study Of Talahridaya Marma In Relation To Blood Pressure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Bartwal |
| Designation |
PG Scholar |
| Affiliation |
Rishikul campus haridwar |
| Address |
PG Department of Rachana Sharir Rishikul Campus ,Uttarakhand Ayurveda University,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077710592 |
| Fax |
|
| Email |
mbdr0501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor |
| Affiliation |
Rishikul campus haridwar |
| Address |
Department of Rachana Sharir ,Room No.1, Rishikul Campus , Uttarakhand Ayurveda University,Haridwar.
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9837352202 |
| Fax |
|
| Email |
dr.naresh2266@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Bartwal |
| Designation |
PG Scholar |
| Affiliation |
Rishikul campus haridwar |
| Address |
PG Department of Rachana Sharir Rishikul Campus ,Uttarakhand Ayurveda University,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077710592 |
| Fax |
|
| Email |
mbdr0501@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurveda University |
|
|
Primary Sponsor
|
| Name |
Dr Manish Bartwal |
| Address |
PG Department of Rachana Sharir Rishikul Campus Haridwar |
| 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 Naresh Kumar |
Rishikul Campus , Uttarakhand Ayurveda University . |
Department of Rachana Sharir ,Room No.1, Rishikul Campus , Uttarakhand Ayurveda University,Haridwar
Hardwar
UTTARANCHAL |
9837352202
dr.naresh2266@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: AAE-8, (2) ICD-10 Condition:R030||Elevated blood-pressure reading, without diagnosis of hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: , Procedure details: 1.Tala Hridaya Marma will be stimulated by pressing with thumb in coherence with breathe of patients for 12 to 15 times per minutes twice a day.
2.The reading of Blood pressure will be recorded during pre-therapy and post therapy of every visit.
3.In due course the patient will be taught to press this Marma with thumb of opposite hand for three minutes twice a day i.e. morning and evening.
4.After thorough instructions about self Marma stimulation, the patient will be trained for it )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Volunteers without any complications
2.Systolic blood pressure 120-139mmhg
3.Diastolic blood pressure 80-89mmhg |
|
| ExclusionCriteria |
| Details |
1.Patients having hypertension due to secondary disease
2.Any serious medical or surgical illness
3.Patients having complications of hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in blood pressure |
Base line
1 week
2 week
3 week
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Headache |
day 0
day 28 |
| vertigo |
day 0
day 28 |
| Tinnitus |
day 0
day 28 |
| Palpitation |
day 0
day 28 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/02/2023 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Marma science is one of the special aspects deeply elaborated by Ayurveda. Marma are several vital points on the
body having importance regarding traumatic effect. These points when exposed to trauma generate the symptoms
from pain to fatal effect. These points should be protected from injury. On the other hand these marma are
considered as healing points. |