CTRI Number |
CTRI/2025/04/084616 [Registered on: 11/04/2025] Trial Registered Prospectively |
Last Modified On: |
08/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Agnikarma] |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Effect of Shallaki and Agnikarma in Sandhigat vata |
Scientific Title of Study
|
EVALUATION OF COMBINED EFFICACY OF AGNIKARMA AND SHALLAKI IN THE MANAGEMENT OF JANU SANDHIGAT VATA WITH SPECIAL REFERANCE TO KNEE JOINT OSTEOARTHRITIS: A RANDOMIZED CLINICAL TRIAL |
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 Sanjeev Yadav |
Designation |
PhD Guide |
Affiliation |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, Navi Mumbai |
Address |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210
Mumbai MAHARASHTRA 410210 India |
Phone |
9322456999 |
Fax |
|
Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nishad Pralhad Patil |
Designation |
PhD scholar |
Affiliation |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, Navi Mumbai |
Address |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210
Mumbai MAHARASHTRA 410210 India |
Phone |
9527464456 |
Fax |
|
Email |
drnishad27p@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nishad Pralhad Patil |
Designation |
PhD scholar |
Affiliation |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, Navi Mumbai |
Address |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210
Mumbai MAHARASHTRA 410210 India |
Phone |
9527464456 |
Fax |
|
Email |
drnishad27p@gmail.com |
|
Source of Monetary or Material Support
|
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210, Maharashtra, India. |
|
Primary Sponsor
|
Name |
Dr Nishad Pralhad Patil Self |
Address |
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210 |
Type of Sponsor |
Other [Self Finance] |
|
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 Nishad Pralhad Patil |
YMT Ayurvedic Medical College, Kharghar, Navi Mumbai |
OPD No 4, Shalyatantra department.G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210
G.D.Pol foundation, YMT Ayurvedic Medical college, Kharghar, sector 4, Navi Mumbai 410210 Mumbai MAHARASHTRA |
09527464456
drnishad27p@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
YMT Ayurvedic College and Hospital, Kharghar, Navi Mumbai |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: SANDHIGATAVATAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shallaki Capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: No any | 2 | Intervention Arm | Procedure | - | agnikarma अग्निकर्म | (Procedure Reference: Sushrut Samhita, Procedure details: Patient will be asked to sleep in supine position.
Most tender parts will be identified and confirming by patient and marked by the marker.
After that Agnikarma Shalaka will be heated on flame up to get red hot and touched to the all-marked point for less than second and removed as per Agnikarma vidhi mentioned in Sushrut Samhita for ‘Twak dagdha.’12
• After that Shatatdhaut ghrita will be applied instantly to the burn points.
And Patient asked to take rest for 30 minutes not to wet burn site for 24 hrs. not to do heavy tasks.
4 settings will be given on 1st day, 7th, 14th, 21th day.) (1) Medicine Name: Shallaki Capsule, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: tds, Duration: 30 Days | 3 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Samhita, Procedure details: Patient will be asked to sleep in supine position.
Most tender parts will be identified and confirming by patient and marked by the marker.
After that Agnikarma Shalaka will be heated on flame up to get red hot and touched to the all-marked point for less than second and removed as per Agnikarma vidhi mentioned in Sushrut Samhita for ‘Twak dagdha.’12
• After that Shatatdhaut ghrita will be applied instantly to the burn points.
• And Patient asked to take rest for 30 minutes not to wet burn site for 24 hrs. not to do heavy tasks.
4 settings will be given on 1st day, 7th, 14th, 21th day.
) (1) Medicine Name: Shallaki Capsule, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: tds, Duration: 30 Days |
|
|
Inclusion Criteria
|
Age From |
45.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patient suffering from Janu sandhigat vata w.s.r. to Knee joint osteoarthritis from 2 or less than 2 years will be selected for study.
Patient between the age group 45-60 years.
Patient will be selected irrespective of sex, religion, occupation, socioeconomic status after clinical diagnosis of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis as per international classification of disease ICD 11.10
|
|
ExclusionCriteria |
Details |
Known case of Diabetes Melitus.
Known case of Spondylolisthesis.
Known case of R.A.
• Known case of Osteosarcoma.
Known case of Tuberculosis of knee.
Known case of Diabetic neuropathy.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the combined efficacy of Agnikarma and Shallaki versus Agnikarma and Shallaki alone in the management of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis. |
1st day, 7th day , 14th day , 21th day,. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Changes in X ray and prevalence of wound infection after agnikarma |
1st day, 7th, 14th, 21th day |
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
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 |
Date of First Enrollment (India)
|
01/11/2025 |
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 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 - 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drnishad27p@gmail.com].
- For how long will this data be available start date provided 05-04-2027 and end date provided 05-04-2032?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
This study is aim to evaluate the combined efficacy of Agnikarma and Shallaki versus Agnikarma and Shallaki alone in the management of Janu sandhigat vata w.s.r. to Knee joint osteoarthritis, and objectives of this study are, to evaluate the efficacy of Shallaki and Agnikarma alone in reducing pain and improving joint function in Janu Sandhigat Vata for 30 days. To assess the combined efficacy of Shallaki and Agnikarma in managing Janu Sandhigat Vata for 30 days. To compare the combined efficacy of Shallaki and Agnikarma with their individual effects on pain relief and joint function in Janu Sandhigat Vata for 30 days. and secondary objective is to estimate the prevalence of wound infection at the Agnikarma site within trial period (30 days) using clinical assessment. Randomly selected 99 patients fulfilling inclusive criteria will be divide in to 3 groups namely A, B, C. GROUP A: n=33 Agnikarma will be performed at knee joint , GROUP B: n=33 Shallaki Niryas capsule, GROUP C: n=33 Agnikarma with Shallaki Niryas Capsule. Duration of therapy will be 30 days. with follow up 1st day, 7th, 14th, 21th day. Outcome variables will be changes in the KOOS Scale and X- ray Knee joint (Kellgren-Lawrence Classification of Osteoarthritis) This study will evaluate the combined efficacy of Agnikarma and Shallaki Niryas capsule.
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