CTRI/2023/05/052418Not yet recruitingPhase 2/3
A Randomised Comparative Trial On Agnikarma And Jalaukavacharana In Janu Sandhigata Vata With Specail Reference To Knee Osteoarthritis
National Institute of Ayurveda ,Jaipur1 site in 1 country30 target enrollmentStarted: May 15, 2023Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in WOMAC scale.
Study Overview
Brief Summary
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will
be selected. All the participants who voluntarily agree to participate and provide informed written
consent for participation will be recruited in the study.
Total 30 participants will be selected after details examination and divided in 2 group of 15 patients
each as per study protocol. All Procedures will be executed done under aseptic condition . Patient will be taken for follow-up
initially 7 th day ,14 th day , 21 st day ,follow up for next 4 weeks ( 15 days interval ).
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 50.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age : Patients of either gender between age 50 -70 yrs.
- •Grade 0 to Grade 3 as per Kellgren and lawrence classification system.
- •Positive Radio-logical findings upto grade
- •With typical clinical classical features of Janu Sandhigata Vata and OA Knee.
Exclusion Criteria
- •Rheumatoid arthritis, Gouty arthritis, osteomyelitis and septic arthritis of knee joints.
- •Patients with local infection or skin diseases on the proposed site of Agnikarma or Jalauka Avcharana.
- •Patients suffering from cardiovascular diseases, HIV, hepatitis, hypertension, anemia and bleeding disorders.
- •Contraindications for Agnikarma.
- •Contraindications for Raktamokshana Karma.
- •History of surgical intervention on knee joint.
Outcomes
Primary Outcomes
Change in WOMAC scale.
Time Frame: 51days
Secondary Outcomes
- Assessment of patient satisfaction criteria after the intervention.(51 days)
Investigators
Study Sites (1)
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