| CTRI Number |
CTRI/2024/12/078562 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effectiveness of Marma Chikitsa and Agnikarma for knee pain relief. |
|
Scientific Title of Study
|
A Comparative Study on the Efficacy of Marma Chikitsa and Agnikarma in the Management of Knee Joint Pain |
| Trial Acronym |
MAP-KNEE TRAIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MAYUR MHASKE |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9130951934 |
| Fax |
|
| Email |
mayurmhaske91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAYUR MHASKE |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9130951934 |
| Fax |
|
| Email |
mayurmhaske91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMOL DESHPANDE |
| Designation |
Associate Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION RESEARCH |
| Address |
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9146131519 |
| Fax |
|
| Email |
deshpandeamol86@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE HIRAPUR SALOD WARDHA |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi ayurved college hospital and research centre hirapur salod wardha |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| 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 MAYUR MHASKE |
Mahatma gandhi ayurved college hospital and research centre hirapur salod |
Department of Anatomy
Mahatma Gandhi Ayurved College Hospital and Research Centre , Salod, Wardha
Wardha
MAHARASHTRA |
9130951934
mayurmhaske91@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma gandhi ayurved college hospital and research centre institutional ethics committee salod wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut samhita, Procedure details: Pre-procedural method:
✓
Obtained the consent regarding the procedure.
✓
Position the subject in a chair, or sitting or lying on a bed.
✓
Identify the point of maximum pain & mark it with marker.
Procedural method:
✓
By using the Gas Burner Agni Shalaka (Copper) is heated up to Red Hot color
✓
Red Hot Shalaka is placed over the Marked area up to the Samyakdagdha Sign
✓
Procedure will be conducted in doted manner.
Post-procedural method:
✓
After the procedure Fresh Alovera Pulp apply over Agnikarma Area
✓
Procedure will repeat after 7 days.)
| | 2 | Comparator Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: SHUSHRUT SAMHITA, Procedure details: Pre-procedural method:
✓ Check the consent regarding the procedure
✓ Keep the patient Supine Position,
Procedural method:
✓ Identify the site of the Marma
✓ Stimulate each Janu ,urvi,ani,indrabasti,Gulpha Marma by pressing it for 15/16 times for 1 second.
✓ Repeat this procedure thrice with resting period of 5 min in between.
✓ Procedure will repeat after 7 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent.
• Patients of either gender between 20 and 60 years.
• Patients with pain in knee Joint
• Patients fit for Marma and Agnikarm Chikitsa |
|
| ExclusionCriteria |
| Details |
1. Patient age group less than 20 years and exceeding 60 years are to be excluded (27)
2. Patients are not willing to undergo trial.
3. Fracture and accidental trauma related to knee joint
4. Patient suffering from diabetes mellitus, tubercular arthritis, etc.
5. Patients of Alpa Satva, Avar Sahanam, pregnant woman. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from pain in knee joint |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement WOMAC index
Improvement in Range Of Motion
Increase in walking time |
3 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="78"
Sample Size from India="78"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
13/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mayurmhaske91@gmail.com].
- For how long will this data be available start date provided 14-01-2025 and end date provided 13-10-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per the computer-generated table. Clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups The trial is a two-arm parallel group randomized open labelled standard control equivalence clinical trial. It will include a 15-day treatment period and an 1st day, 7th day, and 15th day follow-up period after 3 visits.
|