| CTRI Number |
CTRI/2024/06/069013 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [marma therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Marma Therapy in Mangement of Pain and Stiffness of Shoulder Joint |
|
Scientific Title of Study
|
Evaluating the efficacy of Marma Therapy in Post traumatic pain and stiffness of Shoulder Joint |
| 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 Neelam Dhabhai |
| Designation |
MD SCHOLAR |
| Affiliation |
Post graduation institute of Ayurveda, jodhpur |
| Address |
PG Department of Rachana Sharir Post Graduate Institute of
Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784245742 |
| Fax |
|
| Email |
dhabhaineelam28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEELAM DHABHAI |
| Designation |
MD SCHOLAR |
| Affiliation |
Post graduation institute of Ayurveda, jodhpur |
| Address |
PG Department of Rachana Sharir Post Graduate Institute of
Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784245742 |
| Fax |
|
| Email |
dhabhaineelam28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mahandra Sharma |
| Designation |
Head of Department |
| Affiliation |
Post graduation institute of Ayurveda, jodhpur |
| Address |
PG Department of Rachana Sharir Post Graduate Institute of
Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166191561 |
| Fax |
|
| Email |
Vdmahendrasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda,Jodhpur(Rajasthan, India) 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Type of Sponsor |
Government medical college |
|
|
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 Neelam Dhabhai |
Post Graduate institute of ayurveda |
Pg department rachana sharir, opd num. 11, Dr Sarvepalli
Radhakrishnan
Rajasthan Ayurveda
University, Jodhpur,
Rajasthan
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9784245742
dhabhaineelam28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIA Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M259||Joint disorder, unspecified. Ayurveda Condition: ABIGHATAH, |
|
|
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: Susruth Sharir 6/16,6/37, Procedure details: PROCEDURE (SOP)-
MARMA THERAPY
The patient will be made to sit on the chair in comfortable position.
Stimulation of each Marma point will be done at least 18 times by applying constant tolerable pressure of .8s (cardiac cycle)followed by relaxation in a constant rhythamic pattern.The same procedure will be done 3 times daily.
Patient will be advised to take complete rest for 10 minutes in a comfortable manner.
Duration: Usually 18 minutes)
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate and is diagnosed with
post traumatic shoulder injury. |
|
| ExclusionCriteria |
| Details |
1.Tuberculosis of shoulder joint.
2.Sprengel’s shoulder (Congenital elevation of the scapula)
3.Non – traumatic conditions and systemic disorders.
4.Female patients having pregnancy, breast feeding period and delivery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marma Therapy will be effective to ameliorate post traumatic pain and stiffness of shoulder joint.
|
45 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Therapy will be provide a safe and effective treatment |
45 DAYS |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/06/2024 |
| 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 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
|
Materials and Methods: The study will be conducted through three main approaches: Review of Ayurvedic Literature: Literary references will be collected from Ayurveda classics, commentaries, modern literature, PubMed, Google Scholar, and Ayush research journals. Previous research work and internet sources will also be analyzed. Cadaveric Study: Dissection will be performed at the region of Amsa pradesh Marma in the PG department of Sharira Rachana, University college of Ayurveda, Jodhpur (Raj). The structures related to the Marma will be identified, analyzed, and compared with Ayurvedic literature and contemporary sciences. Clinical Study: A clinical trial involving 30 patients diagnosed with post traumatic injuries on the shoulder joint will be conducted. The patients will receive Marma therapy on the amsa pradesha Marma. The patients’ progress will be monitored with regular follow-ups every 7 days for a total trial duration of 45 days. Aims and Objectives: The primary objectives of this study are as follows: To comprehensively study Marma Shareera, particularly focusing on Amsa pradesh Marma. To explore the Vaikalyakara Marma in detail and analyze it in the context of regional and applied anatomy as described in contemporary science. To perform a cadaveric dissection to study the structures related to amsa pradesh Marma. To compare the anatomical changes that occur at Amsa Sandhi after severe traumatic injuries with the Granthokta Viddha Lakshanan of Amsa Marma. To evaluate the therapeutic effect of Marma therapy in managing common sports injuries. STUDY DESIGN:- Study type-Single arm clinical trial. Interventional model- one group Allocation- Randomized Masking- Open level Purpose- Pain and stiffness management. Timing- 3Months End point- Efficacy Group – one PROCEDURE (SOP)- MARMA THERAPY • The patient will be made to sit on the chair in comfortable position. • Stimulation of each Marma point will be done at least 18 times by applying constant tolerable pressure of .8s (cardiac cycle)followed by relaxation in a constant rhythamic pattern.The same procedure will be done 3 times daily. • Patient will be advised to take complete rest for 10 minutes in a comfortable manner. Duration: Usually 18 minutes
|