An Open Label Comparative Clinical Trial to evaluate the efficacy of Yakritshul Vinasini Vatika and Arogyavardhini Vati in the management of Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- This will be assessed based on the improvement in ALT level in the patients of NAFLD
研究概览
简要总结
Over the past few decades, Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) have become leading causes of chronic liver disease worldwide in individuals without significant alcohol intake. Closely linked with obesity, metabolic syndrome, type 2 diabetes, and dyslipidemia, NAFLD develops when liver fat exceeds 5–10% of its weight. In Ayurveda, it is considered a lifestyle-related Yakrit Roga, categorized as Santarpanjanya Vyadhi, caused by overnutrition, oily and spicy foods, and sedentary habits, leading to Kapha dosha prakopa, Agnimandya, and Dooshit Rasa, which impair liver function. Vitiated Kapha and Meda Dhatu accumulate in the liver, obstructing channels and causing hepatomegaly. Most patients are asymptomatic and diagnosed incidentally through LFTs or imaging. Common symptoms include loss of appetite, constipation, flatulence, abdominal discomfort, and nausea. Globally, NAFLD affects about 24% of people; its prevalence is 94% in obese, 67% in overweight, and 25% in normal-weight individuals. In type 2 diabetes, prevalence ranges from 40–70%, with variation by ethnicity and gender. In India, about one-third of adults have NAFLD, with rural Haryana showing a 30.7% prevalence
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
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Randomly selected irrespective of their caste, religion and sex.
- •Non-Alcoholic i.e.Total abstainer of alcoholic intake.
- •USG confirmed Grade I or Grade II fatty liver.
- •The patients with signs and symptoms of NAFLD, Yakritroga are mentioned in the text.
- •The ratio of AST and ALT less than 2 NAFLD diagnosed patients confirmed by USG with or without symptoms like anorexia, fatigue, and abdominal discomfort.
- •Voluntary assigned and enrolment of participants in the study.
排除标准
- •USG showing grade III fatty liver.
- •AST and ALT ratio greater than 2 Presence of any other identified cause of liver disease Portal hypertension, Ascites, viral hepatitis, Liver parenchymal disease, HCC, Wilson disease, Cirrhosis or any other conditions interfering with the result of the treatment of NAFLD.
- •history of Cardiac Arrhythmia, MI, Acute coronary syndrome, Stroke Syndrome, and other cardiac symptoms, Severe within the last 6 months, and comorbidities.
- •Patient with Symptomatic congestive cardiac failure.
- •Uncontrolled pulmonary function, Diabetes Mellitus, chronic kidney disease other severe and chronic diseases.
- •Serum creatinine greater than 1.2mg per dl.
- •Malignancies, HIV, TB, other infectious diseases pregnancy and lactating women Taking Corticosteroids and antidepressants, anti cholinergic, hepatotoxic medications or any other drugs for more than 6 weeks that influences the outcome of the study.
- •Alcoholics and any other drug abusers.
- •Patient has a history of hypersensitivity to the trial drug or any of its ingredients.
结局指标
主要结局
This will be assessed based on the improvement in ALT level in the patients of NAFLD
时间窗: 60 days
次要结局
- This will be assessed based on improvement in subjective(parameters and other test parameters i.e. AST level, Alkaline Phosphate, serum cholesterol and)
研究者
Dr Shubhi Mishra
INSTITUTE FOR AYURVED STUDIES AND RESEARCH