| CTRI Number |
CTRI/2025/02/081121 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF MARMA CHIKITSA AS AN ADD-ON THERAPY IN TYPE 2 DIABETES MELLITUS. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF EFFECT OF MARMA CHIKITSA AS ADD-ON THERAPY ON DIABETES MELLITUS TYPE 2 SUBJECTS ON BLOOD SUGAR LEVEL AND QUALITY OF LIFE PARAMETERS†|
| 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 Anish Kumar Pathak |
| Designation |
ASST PROF, Ph.D Scholar |
| Affiliation |
Sri Sai Institute of Ayurvedic Research and Medicine |
| Address |
Sri Sai Institute of Ayurvedic Research and Medicine Rani Avantibai Marg Kolar Road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7999292904 |
| Fax |
|
| Email |
anishpathak1604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
DrSarvepalli Radhakrishnan Rajasthan Ayurved University Jodhapur |
| Address |
Department of Rachana Sharir DrSarvepalli Radhakrishnan Rajasthan Ayurved University Jodhapur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166216760 |
| Fax |
|
| Email |
rksharma69jumbo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anish Kumar Pathak |
| Designation |
PhD Scholar/ Assistant professor |
| Affiliation |
Sri Sai Institute of Ayurvedic Research and Avantibai Marg Medicine RaniKolar Road Bhopal |
| Address |
Sri Sai Institute of Ayurvedic Research and Medicine Rani Avantibai Marg Kolar Road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7999292904 |
| Fax |
|
| Email |
anishpathak1604@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Post Graduate Institute Of Ayurved Study and Research DSRRAU Jodhapur |
|
|
Primary Sponsor
|
| Name |
UPGIASR RAU Jodhpur Rajasthan |
| Address |
University Post Graduate Institute Of Ayurved Study and Research DSRRAU Jodhapur |
| 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 Anish Kumar Pathak |
Sri Sai Institute of Ayurvedic Research and Medicine Rani Avantibai Marg Kolar Road Bhopal |
Sri Sai Institute of Ayurvedic Research and Medicine Rani Avantibai Marg Kolar Road Bhopal
Bhopal
MADHYA PRADESH |
7999292904
anishpathak1604@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:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Sushrut Samhita Sharir 6, Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pre diabetic and diabetic 2.Patients who are on same medicine for longer duration.3.Individual which falls under diagnostic criteria.4. Already diagnosed cases of pre diabetic and diabetic 5. individual willing to be registered for study. |
|
| ExclusionCriteria |
| Details |
1.Subject having any congenital elbow end wrist joint disorder.
2.Pregnancy, Post Natal Care, Lactating women.
& menstrual phase 3. Chain smoker, heavy drinker. 4.Subject having monoplegia, paraplegia. 5.other associated condition. 6. Traumatic, Infective, Neoplastic condition of patient. 7.Individual suffering from infection like viral, bacterial and fungal. 8.Individual who is suffering from any systemic or metabolic disorders (Hypertension,
Tuberculosis, Thyroid). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in BSL Or any symptoms |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in quality of life |
12 week |
|
|
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)
|
03/03/2025 |
| 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="4"
Months="5"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Diabetes Mellitus is a global problem, and India is likely to be the diabetic capital of the world by 2030. To address this global issue holistic, integrated approach is the need of the hour. present study is an attempt to see the effect of non-invasive classical Marma therapy (A unique method where a particular point is pressed in a desired way for a fixed time) on Blood Sugar Level or QOL or both. |