| CTRI Number |
CTRI/2025/08/093588 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To see the Comparative effect of marma in Janu Sandhigata vata (osteoarthritis) |
Scientific Title of Study
Modification(s)
|
A Randomized Triple Arm Clinical Trial to compare the Efficacy of Marma Chikitsa by three different protocols in Janu Sandhigata Vata w.s.r to osteoarthritis of knee 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 |
Joshi Rutvik Pradipbhai |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Room No 103 Department Of Shalya Tantra Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
6363058109 |
| Fax |
|
| Email |
rpjosh3125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika |
| Designation |
Associate Professor |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Room No 103 Department Of Shalya Tantra, Institute for Ayurved Studies and Research, Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9896873083 |
| Fax |
|
| Email |
dranamikashalyavida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joshi Rutvik Pradipbhai |
| Designation |
Pg Scholar |
| Affiliation |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Room No 103 Department Of Shalya Tantra, Institute for Ayurved Studies and Research, Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
6363058109 |
| Fax |
|
| Email |
rpjosh3125@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Institute for Ayurved Studies and Research , Shri Krishna AYUSH University,Umri Road Sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Other [Goverment Ayurvedic 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 Joshi Rutvik Pradipbhai |
Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Room No 103 Department Of Shalya Tantra, Institute for Ayurved Studies and Research, Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA |
6363058109
rpjosh3125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SKAU Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsa, मर्मचिकित्सा | (Procedure Reference: Shurshut Sharir sthan , Procedure details: (Protocol 1 – Local Marma Stimulation)
Marma Points- Janu Marma
Technique- Gentle, sustained digital pressure & circular stimulation (moderate pressure, avoiding excessive pain).
Duration: 3–5 minutes per Marma, total ≈ 10 minutes/session
Follow up on 21st & 28th day )
| | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: Sushru Sharir Sthan, Procedure details: (Protocol 2 – Regional Marma Stimulation)
Marma Points-Janu, Ani & Indrabasti Marma
Technique-Sequential stimulation of Janu, Ani followed by Indrabasti using rhythmic pressure & release.
Duration: 3–4 minutes per Marma, total ≈ 15 minutes/session
Frequency-Once daily for 14 consecutive days
Follow up on 21st & 28th day )
| | 3 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: Sushrut Sharir Sthan, Procedure details: (Protocol 3 – Comprehensive Marma Stimulation)
Marma Points-Janu, Ani, Urvi, Indrabasti, Kshipra, Gulpha
Technique-Standardized stimulation applied sequentially from proximal (Janu, Ani, Urvi) to distal (Indrabasti, Kshipra, Gulpha).
Duration: 2–3 minutes per Marma, total ≈ 20–25 minutes/session
Frequency: Once daily for 14 consecutive days
Follow up on 21st & 28th day )
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of second- grade osteoarthritis of knee joint as explained in modern
text books.
Patient between the age of 35-70 years.
Patients of both sexes.
Patients who will be willing for the treatment. |
|
| ExclusionCriteria |
| Details |
Pregnant Women. Secondary osteoarthritis (Amavata and Vatarakta etc.).
Patients with systemic diseases like Uncontrolled Diabetes, Uncontrolled Hypertension, Patients with
major disorder like Neoplastic conditions of knee.
T.B. Knee Joint.
Patient undergoing other modalities of treatment for Janu Sandhivata |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Pain Intensity.
Measured before treatment, weekly during intervention, and after completion of therapy.
Improvement in Joint Function and Mobility
Evaluated through the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)—
which assesses pain, stiffness, and physical function.
Pre- and post-treatment comparison will indicate improvement in knee joint functionality. |
1st - 0 day
2nd - 21st day
3rd -28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healthy lifestyle |
1st - 0 day
2nd - 21st day
3rd -28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="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
|
The study compares three therapeutic protocols involving specific Marma points. Group 1 receives intervention on Janu Marma alone; Group 2 is treated with Janu, Ani, and Arvi Marma; while Group 3 undergoes therapy on a broader set, including Janu, Ani, Arvi, Indrabasti, Kshipra, and Gulpha Marma. The trial aims to determine comparative outcomes in pain reduction, joint mobility, and functional improvement, providing evidence-based validation of Marma therapy. |