| CTRI Number |
CTRI/2025/08/093732 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Effects of Agnikarma Therapy on Knee Osteoarthritis and Inflammation |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Agnikarma on Knee Osteoarthritis and Pro-inflammatory Biomarkers |
| 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 Sapna Yadav |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Shalya Tantra
National Institute of Ayurveda
Deemed To Be University
Jorawer Singh Gate Amer Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619414716 |
| Fax |
|
| Email |
sapnayadav35395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Yadav |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Shalya Tantra
National Institute of Ayurveda
Deemed To Be University
Jorawer Singh Gate Amer Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619414716 |
| Fax |
|
| Email |
sapnayadav35395@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Sharma |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University |
| Address |
Department of Shalya Tantra
National Institute of Ayurveda
Deemed To Be University
Jorawer Singh Gate Amer Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418159666 |
| Fax |
|
| Email |
sumanhp2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda
Jorawer Singh Gate, Amer Road, Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jorawer Singh Gate Amer Road Jaipur Rajasthan |
| Address |
Department of Shalya Tantra
National Institute of Ayurveda
Deemed To Be University
Jorawer Singh Gate Amer Road Jaipur Rajasthan
|
| Type of Sponsor |
Research institution and hospital |
|
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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 Sapna Yadav |
National Institute of Ayurveda, Hospital |
Department of Shalya Tantra
National Institute of Ayurveda
Deemed To Be University
Jorawer Singh Gate Amer Road Jaipur Rajasthan
Jaipur
RAJASTHAN |
08619414716
sapnayadav35395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National institute of Ayurveda, Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: osteo, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Susruta Samhita, Procedure details: The procedure will be performed in three stages as Purva Karma (Pre-procedures), Pradhana Karma (Main- procedures), & Paschata Karma (Post- procedures) mentioned by Acharya Sushruta.)
|
|
|
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Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Grade 2 knee osteoarthritis as per Kellgren and Lawrence classification system |
|
| ExclusionCriteria |
| Details |
Patients with Rheumatoid arthritis, gouty arthritis, osteomyelitis and septic arthritis of knee joints.
Patients with local infection or skin diseases on the proposed site of Agnikarma.
Patients suffering from cardiovascular diseases, HIV, hepatitis, diabetes mellitus.
Contraindications for Agnikarma9.
History of trauma to knee joint.
History of surgical intervention on knee joint.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in symptoms of knee osteoarthritis as per WOMAC scale baseline and after treatment |
Change in symptoms of knee osteoarthritis as per WOMAC scale baseline and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Pro-inflammatory biomarkers in blood after Agnikarma in knee osteoarthritis baseline & after treatment
Identification of type of the Prakriti most vulnerable to Knee Osteoarthritis.
Change in the quality of life of the patient
|
Safety |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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 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 - NO
|
|
Brief Summary
|
Background: brief review of literature Osteoarthritis is a very common joint disease characterized by the destruction of joint cartilage. It is produced by mechanical stress over the joint and it manifests as swelling, stiffness, and joint pain. Osteoarthritis of the knee is a leading cause of chronic disability in the elderly, prevalence of knee osteoarthritis rises with age and is more in females than in males1. The knee joint is the most complex and largest joint of the body and is most vulnerable to damage because it is a mobile and weight-bearing joint.2 Knee osteoarthritis is one of most common form of arthritis in synovial joints. Synovial membrane inflammation plays an important role in the development of pain, joint inflammation, and cartilage destruction. Hence, pro-inflammatory mediators also play an important role in osteoarthritis. Knee osteoarthritis can be co-related with Janu Sandhigatavata because it resembles in signs and symptoms of Sandhigatavata told in Ayurveda literature such as Sandhi Shula and Shoth in affected joints.3,4 In contemporary science, a wide range of treatment modalities are available such as anti-inflammatory, analgesics, calcium and vitamin D supplements, steroids, but have limited prognosis due to side effects after prolonged use. So, there is a need for better treatment modalities to manage the signs and symptoms of knee osteoarthritis. Treatment for knee osteoarthritis in contemporary medicine begins with conservative methods and progresses to surgical treatment options when conservative treatment fails. No proven disease- modifying agents for the treatment of knee osteoarthritis currently exist. Though Knee OA is not life life-threatening condition it seriously hampers the quality of life of patients. So, when there is no definitive treatment protocol available for this condition in modern science, this study becomes crucial in finding the solution in Ayurveda in terms of Agnikarma with Shalaka.
RESEARCH QUESTION Does Agnikarma have any Efficacy on knee osteoarthritis and the level of the serum pro-inflammatory biomarkers? HYPOTHESIS Null Hypothesis (H0) There is no efficacy of Agnikarma and no change in the level of the pro-inflammatory biomarkers in the blood after Agnikarma in Knee Osteoarthritis. Alternate Hypothesis (Ha) There is an efficacy of Agnikarma and a change in the level of the pro-inflammatory biomarkers in the blood after Agnikarma on Knee Osteoarthritis.
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