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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther 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
2Intervention ArmProcedure-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
3Comparator ArmProcedure-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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drnishad27p@gmail.com].

  6. 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.

  7. 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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