A Comparative Clinical Study of Siravedhana and Sarpunkhadi Churna Versus Sarpunkhadi Churna Alone in the Management of Non-Alcoholic Fatty Liver Disease NAFLD
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 38
- Locations
- 1
Study Overview
Brief Summary
Non-Alcoholic Fatty Liver Disease NAFLD is a progressively increasing metabolic liver disorder characterized by excessive fat accumulation in hepatocytes without significant alcohol consumption It encompasses a clinical spectrum ranging from reversible steatosis to non alcoholic steatohepatitis fibrosis cirrhosis and hepatocellular carcinoma Grades 1 and 2 representing early stages commonly manifest with mild steatosis metabolic imbalance abdominal discomfort bloating fatigue and altered liver echotexture on ultrasonography Lifestyle modifications including weight reduction exercise and controlled dietary habits are the primary line of modern management while pharmacotherapy is considered adjunctive for metabolic comorbidities
In Ayurveda NAFLD can be correlated with Yakruta vikar Medodusti and Agnimandya where impaired Jatharagni and Medodhatvagni lead to Ama formation Kapha Medo accumulation and obstruction of Raktavaha srotas Siravedhana a form of Raktamokshana described extensively in Brihattrayi particularly by Sushruta is indicated in conditions of Rakta Pitta aggravation and Yakruta pleeha vikaras It promotes expulsion of vitiated blood reduces inflammatory load and restores doshic equilibrium Sanskrit references specify Siravedhana at right upper extremity sites for Yakrut disorders Sharapunkhadi Churna comprising Sharapunkha Bhumiamalki and Katuki is a hepatoprotective formulation possessing Deepana Pachana Medohara Raktashodhaka and Yakruta uttejaka actions Clinical research shows its effectiveness in reducing liver fat improving digestion and enhancing hepatic metabolism with no reported adverse effects
The present study is a randomized open label interventional clinical trial comparing Siravedhana with Sharapunkhadi Churna versus Sharapunkhadi Churna alone in NAFLD Grades 1 and 2 A total of 30 participants will be assessed over 45 days The intervention group will undergo six weekly Siravedhana sittings along with Sharapunkhadi Churna while the control group will receive only the herbal formulation Parameters such as USG grading lipid profile BMI and subjective symptoms will be evaluated The study aims to establish the therapeutic efficacy of integrating Siravedhana with herbal management as a minimal invasive cost effective Ayurvedic modality for early NAFLD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 60 years Diagnosed case of fatty liver BMI greater than 24 Elevated lipid profile of grade 2 non-alcoholic fatty liver diesease Total Cholesterol Less than 400 mg per dL LDL Cholesterol Less than 200 mg per dL optimal HDL Cholesterol less than 40 mg per dl Triglycerides Less than 500 mg per dL.
- •Informed and written consent for participant.
Exclusion Criteria
- •NAFLD Grade 3 or cirrhosis Diabetes RBS greater than 200 Hb less than 10 Pregnancy or lactation Bleeding disorders Alcoholic liver disease Coagulopathies Acute abdominal pain Contraindications of raktmokshan.
Investigators
Dr Dhruv Kachhia
Shree Swaminarayan Ayurvedic College kalol