| CTRI Number |
CTRI/2025/08/093753 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Study on effect of Mrittika Shalaka Agnikarma ( medical heat technique with an instrument made of mud) in knee joint pain with oral ayurvedic medication versus only oral ayurvedic medications. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of agnikarma using mrittika shalaka in the management of janusandhigatavata w.s.r osteoarthritis of the 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 |
Dr Bhavana Sudarshan |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre , Lakshminarayana nagara , P.O. Kuthpady , Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9482881883 |
| Fax |
|
| Email |
sudarsundar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre , Lakshminarayana nagara , P.O. Kuthpady , Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre , Lakshminarayana nagara , P.O. Kuthpady , Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Private 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 Bhavana Sudarshan |
Sri Dharmasthala Manjunatheswara College of Ayurveda , Hospital and Research Centre |
OPD 5, Department of Shalya tantra.
Udupi
KARNATAKA |
09482881883
sudarsundar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Agnikarma using Mrittika Shalaka with Oral medications.)
(1) Medicine Name: Mahayogaraja Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: tds, Duration: 15 Days(2) Medicine Name: Triphala Kwatha, Reference: ASTG Guidelines, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahayogaraja Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Triphala Kwatha , Reference: ASTG guidelines, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with informed consent.
Patient fitting into the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Patients contraindicated for agnikarma as per text.
Uncontrolled diabetes mellitus - RBS more than 200mg/dL
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain
2.Swelling
3.Stiffness |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Movement |
15 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Osteoarthritis is a disease where degenerative changes occur prominently in the knee joint characterized by chronic pain and functional disability. Contemporary science offers conservative management in the form of NSAIDS, Steroids, Analgesics and various surgical procedures like Osteotomy, Arthroplasty and Knee Joint replacement, which are expensive and need a longer period of recovery with supportive care such as Physiotherapy.
The various classical treatment modalities prescribed for Sandhigata vata are Sneha , Upanaha, Bandhana and Agnikarma etc. Diseases treated with Agnikarma are depicted as Apunarbhava. Severe pain in the Twak, Mamsa, Sira, Snayu, Sandhi, Asthi caused by Vata can be cured by Agnikarma. Different types of Dahana Upakaranas are also explained. |