A Randomized comparative clinical study to evaluate the efficacy of Rohitakadi vati and Pippali vati orally after Virechana in Non-alcoholic fatty liver disease.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in symptoms of Non alcoholic fatty liver disease- Nausea,Pain abdomen, Burning sensation inabdomen, belching, flatulence, constipation , Changes in Chronic liver disease Questionnaire
研究概览
简要总结
Over the past couple of decades, it has become increasingly clear that nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are the significant causes of liver disease. NAFLD is now the most prevalent form of chronic liver disease, affecting 20%–30% of the general population.NAFLD is a leding cause of liver disease worldwide. The estimated global incidence of NAFLD is 47 cases per 1,000 population and is higher among males(40%) than females(32%) Within the next 10 years, it is expected to become the leading cause of liver pathology, liver failure, and indication for liver transplantation. The prevalence of fatty liver disease in India is found to be as high as 24%,which is similar to that reported in some of the Western countries, where it correlates with the prevalence of obesity. Starting from a simple steatosis, NAFLD can proceed to steatohepatitis and fibrosis. Cirrhosis and/or hepatic carcinoma can be its terminal complication.
The aim of this study is to compare the efficacy of Rohitakadi vati and Pippali vati orally after virechana in patients of Non alcoholic fatty liver disease. 200 subjects satisfying diagnosis and inclusion criteria will be divided in to 2 groups of 100 subjects each, Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in their symptoms, BMI, USG abdomen and also their quality of life will be assessed based on chronic liver disease questionnaire.
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
- •1.Clinical signs and symptoms suggesting of NAFLD/Yaká¹›t Roga, that is, pain in right upper quadrant/epigastric region of the abdomen, feeling of nausea, and vomiting, loss of appetite, burning sensation in the abdomen 2.Ultrasonography (USG) abdomen/or other scanning modalities such as contrast-enhanced computed tomography (CECT) abdomen showing fatty infiltration of the liver.
- •USG findings suggestive of fatty liver grade 1, 2, and 3 3.Biochemical: Liver function tests showing raised alanine transaminases (ALT) levels approximately more than 1.5 times the normal limits with/without raised lipid profile and fasting blood glucose levels within normal limits.
排除标准
- •1.Patients in whom alcohol intake exceeded 20 g/day (history of alcohol intake was taken separately from the patients and close relatives) 2.Patients having fasting blood sugar (FBS) ≥200 mg/dl and postprandial blood sugar (PPBS) ≥250 mg/dl, despite taking oral hypoglycemic agents, Stage II hypertension, i.e.,systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100 mmHg, despite taking antihypertensive drugs 3.Patients with complications of metabolic syndrome such as a cerebrovascular accident, myocardial infarction, chronic kidney disease, suffering from cirrhosis, ascites, variceal hemorrhage, coagulopathy, hepatorenal syndrome, consuming hepatotoxic medicines, alcohol or other narcotic substances.
结局指标
主要结局
Changes in symptoms of Non alcoholic fatty liver disease- Nausea,Pain abdomen, Burning sensation inabdomen, belching, flatulence, constipation , Changes in Chronic liver disease Questionnaire
时间窗: 1st assessment-Before treatment (0th day) | 2nd assessment- During treatment(31st day) | 3rd assessment-(61st day)
次要结局
- Changes in USG Abdomen, Changes in SGOT,SGPT, Changes in Lipid profile, Changes in BMI(1st assessment-Before treatment (0th day))
研究者
Dr Harshitha K S
Government Ayurveda Medical College, Hospital and Research centre, Mysuru, Karnataka