| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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.)
| | 2 | Intervention Arm | Procedure | - | 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.)
|
|
|
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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
|
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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. |