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临床试验/CTRI/2026/01/102459
CTRI/2026/01/102459尚未招募2/3 期

A Comparative Clinical Study of Siravedhana and Sarpunkhadi Churna Versus Sarpunkhadi Churna Alone in the Management of Non-Alcoholic Fatty Liver Disease NAFLD

Shree Swaminarayan Ayurvedic College kalol1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年2月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
38
试验地点
1

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Shree Swaminarayan Ayurvedic College kalol
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Dhruv Kachhia

Shree Swaminarayan Ayurvedic College kalol

研究点 (1)

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