| CTRI Number |
CTRI/2025/07/090992 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Marma Chikitsa and Agnikarma ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma chikitsa on vatkantaka |
|
Scientific Title of Study
|
A Comparative Study On Efficacy Of Marma Chikitsa And Agnikarma In The Pain Management Of Vatkantaka |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Rathore |
| Designation |
MD Scholar Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma government Auto Ayurveda College and Institute Bhopal MP 462003 |
| Address |
PG Department of Rachna Sharir Pt Khushilal Sharma Government Auto Ayurveda College and Institute Bhopal MP 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7694971637 |
| Fax |
|
| Email |
aish2298rathore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Bhalerao |
| Designation |
Associate Professor |
| Affiliation |
Pt Khushilal Sharma government Auto Ayurveda College and Institute Bhopal MP 462003 |
| Address |
PG Department of Rachna Sharir Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9424542272 |
| Fax |
|
| Email |
nmandalik10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Rathore |
| Designation |
MD Scholar Department of Rachna Sharir |
| Affiliation |
Pt khushilal sharma government auto ayurveda college and institute Bhopal mp 462003 |
| Address |
Pg department of rachna sharir Pt khushilal sharma government auto ayurveda college and institute Bhopal mp 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7694971637 |
| Fax |
|
| Email |
aish2298rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal MP 462003 |
|
|
Primary Sponsor
|
| Name |
PG Department Of Rachna Sharir |
| Address |
Pt Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal MP 462003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Aishwarya Rathore |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal |
Pg Department Of Rachna Sharir Pt Khushilal Sharma Government Auto Ayurveda College And Institute Bhopal MP 462003
Bhopal
MADHYA PRADESH |
07694971637
aish2298rathore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Once a day for 14 days)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: , Procedure details: Once a day on 0 Day, 7th day & 14th day )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age 20 to 60 years.
2.Patients with symptoms namely pain in plantar aspect of heel, pain on keeping the first step in the morning with or without local swelling, stiffness and tenderness.
3.Patients willing to be registered for study with written consent.
4.Patients of either sex. |
|
| ExclusionCriteria |
| Details |
1.Calcaneal stress fracture, R.A., Gout, Neoplastic condition, nerve entrapment syndromes.
2.Subjects with improper circulation to lower extremities such as DVT, vasculitis.
3.Subjects with referred pain due to sciatica & other neurological disorders.
4.Corticosteroid injections in the heel, preceding 3 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study scholar will be able to evaluate the effect of Marma Chikitsa and Agnikarma in the pain management of Vatkantaka. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Marma Chikitsa Is Non Pharmaceutical Treatment To Treat Pain In Vatkantaka 14 days Edit || Delete
|
14 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/07/2025 |
| 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 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
|
Study Overview The study compares the effectiveness of two Ayurvedic treatments for the pain management of Vatkantaka Treatment Groups Group 1 Marma Chikitsa- 20 patients of this group will be treated with Marma Chikitsa once a day for 14 days treatment involving specific pressure points (Marma points) to relieve pain. Group 2 Agnikarma 20 patients of this group will be treated with Agnikarma Chikitsa for 14 days in every 7th day (0th, 7th,14th day) Expected Outcome The study aims to determine which treatment is more effective in pain managing of Vatkantaka. Possible Results Marma Chikitsa is more effective If Group 1 shows significant improvement in pain management of Vatkantaka symptoms compared to Group 2 Agnikarma Chikitsa more effective If Group 2 shows significant improvement in pain management of Vatkantaka symptoms compared to Group 1 The study’s findings can help to determine the most suitable treatment approach for Vatkantaka |