| CTRI Number |
CTRI/2020/05/025316 [Registered on: 22/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of marma therapy and Hridya amrit vati in high blood pressure |
|
Scientific Title of Study
|
A multi-centre study : comparison of marma therapy and Hridya Amrit Vati in the treatment of stage 1 hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S K joshi |
| Designation |
Vice chancellor Uttarakhand ayurved University |
| Affiliation |
uttarakhand Ayurved University ,Harrawala ,Dehradoon |
| Address |
O.P.D no. 7, department of shalya tantra
Rishikul ayurvedic college haridwar (uttarakhand)
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9897523499 |
| Fax |
|
| Email |
mrityunjaymission@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K joshi |
| Designation |
Vice chancellor Uttarakhand ayurved University |
| Affiliation |
uttarakhand Ayurved University ,Harrawala ,Dehradoon |
| Address |
O.P.D no. 7, department of shalya tantra
Rishikul ayurvedic college haridwar (uttarakhand)
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9897523499 |
| Fax |
|
| Email |
mrityunjaymission@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita khetwal |
| Designation |
P G scholar |
| Affiliation |
uttarakhand Ayurved University ,Harrawala ,Dehradoon |
| Address |
O.P.D no. 7, Department of shalya tantra
Rishikul ayurvedic college haridwar (uttarakhand)
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8439983359 |
| Fax |
|
| Email |
drnikitakhetwal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| uttarakhand ayurved university ,rishikul campus haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand ayurved University Rishikul campus haridwar |
| Address |
Uttarakhand ayurved University Rishikul campus haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S k joshi |
Rishikul Ayurvedic college |
opd no - 7, shalya tantra deparment
uttarakhand ayurved university,rishikul campus haridwar
Hardwar
UTTARANCHAL |
9897523499
mrityunjaymission@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee of Uttarakhand ayurved University |
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 |
| Comparator Agent |
Hridaya Amrit vati along with life style modification and placebo along with life style modification |
it is a three arm study .
comparison will be done between the efficacy of Marma therapy and Hridaya Amrit Vati |
| Intervention |
Marma therapy along with life style modification |
Marma therapy thrice a day will be done along with Life style modification in stage one hypertensive patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects will be enrolled with stage 1 hypertension (130-139/80-89)
Hypertensive patients who are drug-naive will be enrolled for the study
Normal LV function |
|
| ExclusionCriteria |
| Details |
Hypertensive patients with B.P greater or equal to 140 / 90 mmHg
LVEF < 50 %
CKD , Serum creatinine > 1.7 |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lowering in B.P from 140/90 mmhg to the normal ( Acc to the ACC and AHA ) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not any |
not any |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/05/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Globally, hypertension is seen as a leading causes of mortality, as it has role in cardiovascular diseases and stroke . Hypertension is also difficult to manage effectively, as it requires consistent treatment after it is diagnosed, due to lack of awareness and patient compliance. In this study we will see the role of Marma therapy and life style modification in the stage one hypertensive patients . life style modification can be defined as altering the long term unhealthy habits such as over eating , limited physical activity etc . Marma therapy ; it is a therapaeutic healing through subtle energy points in the body . Hypertension can be managed by modern medicine but unfortunately accompanied with unwanted adverse effect . so this study is intends to evaluate the effect of marma therapy along with life style modification in stage 1 hypertension.
|