Effect of Shallaki and Agnikarma in Sandhigat vata

Phase 3

Not yet recruiting

• Conditions: Osteopathic. Ayurveda Condition: SANDHIGATAVATAH,

• Registration Number: CTRI/2025/04/084616
• Lead Sponsor: Dr Nishad Pralhad Patil Self

Brief Summary

This study is aim to evaluate the combined efficacy of *Agnikarma and Shallaki* versus *Agnikarma and Shallaki* alon*e* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-11
• Last Update Posted: 2025-08-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1st day, 7th day , 14th day , 21th day,.

Secondary Outcome Measures

Name	Time	Method
Changes in X ray and prevalence of wound infection after agnikarma	1st day, 7th, 14th, 21th day

Trial Locations

Locations (1)

YMT Ayurvedic Medical College, Kharghar, Navi Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

YMT Ayurvedic Medical College, Kharghar, Navi Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr Nishad Pralhad Patil

Principal investigator

09527464456

drnishad27p@gmail.com