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CTRI Number  CTRI/2025/01/079367 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treating patients suffering from knee osteoarthritis with viddha-agni karma and jalauka-avacharan  
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Role Of Viddha-Agni Karma And Jalauka-Avacharan In Janusandhigata Vata 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushbu Shankarlal Batra 
Designation  Pg scholar (Shalya) 
Affiliation  D.Y. Patil deemed to be university, School of Ayurveda Nerul Navi Mumbai 
Address  Department of Shalya Tantra, 3rd floor, D.Y. Patil deemed to be university, School of Ayurveda Nerul, Navi Mumbai

Thane
MAHARASHTRA
400709
India 
Phone  7517537528  
Fax    
Email  batrakhush22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayur Pawaskar 
Designation  Associate Professor 
Affiliation  D.Y. Patil School of Ayurveda deemed to be university Nerul Navi Mumbai 
Address  D.Y. Patil deemed to be university, School of Ayurveda sector 7, Nerul east ,Navi Mumbai 4000706

Thane
MAHARASHTRA
400709
India 
Phone  9004215670  
Fax    
Email  mayur.pawaskar@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mayur Pawaskar 
Designation  Associate Professor 
Affiliation  D.Y. Patil School of Ayurveda deemed to be university Nerul Navi Mumbai 
Address  Department of Shalyatantra, D.Y. Patil deemed to be university, School of Ayurveda sector 7, Nerul east, Navi Mumbai 400706

Thane
MAHARASHTRA
400709
India 
Phone  9004215670  
Fax    
Email  mayur.pawaskar@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y. Patil deemed to be university, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai 400706  
 
Primary Sponsor  
Name  Khushbu Shankarlal Batra 
Address  D.Y. Patil Deemed to be university School of Ayurveda Sector 7, Nerul east, Navi Mumbai 400706 
Type of Sponsor  Other [Sponsored by Self] 
 
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 Mayur Pawaskar  D.Y.Patil Ayurvedic Hospital  D.Y. Patil Ayurvedic Hospital, 1st Floor, OPD No 3 sector 7, Nerul east, Navi Mumbai
Thane
MAHARASHTRA 
9004215670

mayur.pawaskar@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee D.Y. Patil School of Ayurveda deemed to be university Nerul Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: ASTHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Sushrut Samhita, Procedure details: 1. The desired site will be cleaned with wet gauze. 2. Then, the leech will be held with fingers & applied directly to the skin, 2 to 3 leeches will be applied at a time depending upon the necessity. 3. Leeches will be removed from the site. 4. Tumeric powder applied over bleeding sites. 5. Pressure bandaging will be done to arrest the bleeding.)
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Bhaishajya Ratnavali, Procedure details: 1. The desired site is marked. 2 The area is cleaned with NS solution. 3. 6-7 needles of 26No half inch will be heated till red hot & inserted at the point of maximum tenderness. 4. After 5 to 10 sec needles will be removed & yashtimadhu ghrita is applied at the puncture site.)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patient with symptoms of Janusandhigata Vata.
• Gender – Both male and female.
• Age – within 40-70 years.
• X-Ray showing early degenerative changes 
 
ExclusionCriteria 
Details  Trauma
Osteomyelitis
Pyogenic, Tuberculous Arthritis
Hemophilic Arthritis, Neuropathic Arthritis
Rheumatoid Arthritis
Osteochondritis dissecans
Tears or cyst of the menisci
Deformities-Genu varum, Genu valgum
Intra articular loose bodies
Prepatellar bursitis, Popliteal swelling
Bone tumors
Syphilitic condition
Pregnancy
Severe anemia
Coagulative disorders
Paralysis 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of viddha agni karma and jalaukavacharan in janusandhigata vata such as pain movements of knee joints crepitus tenderness swelling.  the assessment will be done after 3 sittings of the therapy and final asseesment will be done on the 45th day  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the role of Viddha Agnikarma in the management of Janusandhigata Vata such as pain, movements of knee joint, tenderness, crepitus, swelling.
To evaluate the role of Jalaukavacharana in in the management of Janusandhigata Vata such as pain, movements of knee joint, tenderness, crepitus, swelling.
To compare the role of Viddha Agnikarma & Jalaukavacharan in the management of Janusandhigata Vata. 
over the period of 45 days 3 sittings of the procedures will be assessed at equal interval of 15 days. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/02/2025 
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 (OA), the most common joint disorder causing wear and tear of joints. It is a degenerative, non-inflammatory joint disease which is characterized by degeneration of articular cartilage and exposure of the underlying bone that further leads to inflammation of the synovial fluid and thickening of capsule, leading to pain, stiffness and deformity of the joint. It is mainly seen in elderly individuals in the weight-bearing joints like hip, knee, etc. Knee osteoarthritis is caused by mechanical stress to the knee joint which produces symptoms like joint pain, tenderness, swelling, stiffness, crepitus, erythema, restricted movements, etc.
                 In Ayurveda, Knee osteoarthritis can be compared with Janusandhigata vata. Acharya Charaka considered Sandhigata vata under Vatavyadhi as gatatva (localized) vata. When vitiated vatadosha lodges in janusandhi (marmasthana) it destructs janusandhi and manifests Janusandhigata vata. When it combines with vitiated kaphadosha, there will be Stambha and Gaurava.
                  Various treatment principles have been described in samhitas, among them Agnikarma is said to be superior because the patient treated with agnikarma has less chances of recurrence. Acharya Sushruta has explained that agnikarma can be done in condition of severe pain which occurs in twaka, mamsa, sira, snayu, sandhi, asthi. Agnikarma not just mitigates pain but also underlying inflammation. Acharya Dalhan has described that agnikarma is best treatment for vatakaphaja vyadhi. According to Bhavprakash samhita, agnikarma i.e. dahakriya is specifically mentioned in treatment of sandhigata vata. In Bhaishajya ratnavali, one another kind of agnikarma chikitsa is mentioned with the use of needles. It can be correlated with Viddha agnikarma. Viddha agnikarma is combined procedure of vyadhanakarma and agnikarma.
                    Viddha karma is one of the eight Shashtrakarma mentioned by Acharya Sushruta. where in a sterile procedure, hollow needles are pierced at specific points of the body for pain relief. Viddha Agnikarma blocks pain by activating a variety of bioactive chemicals through peripheral, spinal, and supraspinal mechanisms. [9] These include opioids, which desensitize peripheral nociceptors and reduce pro-inflammatory cytokines peripherally and in the spinal cord, and serotonin and norepinephrine, which decrease spinal n-methyl-d-aspartate receptor subunit GluNI phosphorylation to inhibit pain.
                        In Sushruta samhita, bloodletting by means of leech (Jaluaka avacharan) has been advocated as most effective method in the management of all inflammatory conditions. During the process of jalauka avacharan, leeches secrete a complex mixture of different biologically and pharmacologically active substances like Hirudin, Calin, Bdellins, Hyaluronidase, Eglins, Factor Xa inhibitor, enzymes, etc. having anesthetic, anti-inflammatory, anti-coagulative, antibiotic, etc. properties which helps to provide significant relief in the management of symptoms of disease and to break the pathogenesis of disease.
 
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