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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 45.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 1st day, 7th day , 14th day , 21th day,.
Secondary Outcomes
- Changes in X ray and prevalence of wound infection after agnikarma(1st day, 7th, 14th, 21th day)