An Open Label Comparative Randomized Clinical Trial to Evaluate the efficacy of Bruhatyadi Yapana Basti and Patoladi Niruha Basti In the Management of Asthimajjagata Vata W.S.R Avascular Necrosis (AVN) of the Femoral Head
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Institute For Ayurved Studies And Research
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in AsthiShoola Pain in Bones As Per Ayurvedic Criteria
Overview
Brief Summary
This study is a Randomized Open Label Clinical trial to evaluate the efficacy of Bruhatyadi Yapana Basti and Patoladi Niruha Basti in managing Asthimajjagata Vata with special reference to Avascular Necrosis of the Femoral head AVN is a progressive degenerative disorder caused by impaired blood supply parallel symptoms of Asthimajjagata Vata described in Ayurveda contemporary treatments like surgery have limitations whereas basti therapy offers a safe cost effective alternative Forty Patient will be randomly allocated into two groups receiving 16 days of Kala basti regimen The trial aims to compare symptomatic relief functional improvement and potential disease modifying outcomes
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient Having Classical Signs And Symptoms Of Asthimajjagata Vata Patient Having Sign And Symptoms Of Avascular Necrosis Of Femoral Head Either Unilateral Or Bilateral Of Any Stages Patients Yogya For Basti Karma.
Exclusion Criteria
- •Patient Who Is Contraindicated For Basti Patient With Chronic Systemic Illness Cardiac Disease Cirrhosis Of Liver Diabetes Hypertension Chronic Renal Disease Carcinoma Pregnant And Lactating Women Patient With Ano Rectal Disease Patient Of AVN With Fractured Dislocation Severly Deformed Hip Joint Patient Unwilling To Participate In The Trial Patient Aged Below 25 Years And Above 60 Years.
Outcomes
Primary Outcomes
Reduction in AsthiShoola Pain in Bones As Per Ayurvedic Criteria
Time Frame: 1st- 0 day | 2nd- 16th day | 3rd- 32nd day | 4th- 48th day
Secondary Outcomes
- Improvement In Mamsakshaya Muscles Hypotonia Aswapan Santat Ruka Sleeplessness Due To Continuous Pain Balakshaya Muscle Power Grading As Per Ayurvedic Criteria(Follow Up on 16th 32nd 48th Day)
Investigators
Dr Sunita
Institute For Ayurved Studies And Research