AN OPEN-LABEL RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFICACY OF VIRECHANA & GOMUTRA-HARITAKI VERSUS URSODEOXYCHOLIC ACID (UDCA) ON NAFLD FIBROSIS SCORE AMONG NAFLD PATIENTS
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- NAD
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1.Improvement in NAFLD Fibrosis score (Age, Hyperglycaemia, BMI, platelet Count, Albumin, aspartate aminotransferase (AST) /Serum alanine aminotransferase (ALT) ratio) along with changes in clinical presentations (relief of the following symptoms like Fatigue, indigestion, epigastric discomfort, pain abdomen, diarrhea, constipation,)
研究概览
简要总结
we have taken Virechana followed by Gomutra haritaki. We presume that in the light of available scientific references and existing traditional usage, Ayurvedic regime would be effective in the treatment of NAFLD directed toward normalization of liver functions as well as to the reduction of insulin resistance. The present clinical trial was therefore designed to verify this hypothesis with the efforts in searching a more preferable drug having better cost-effectiveness for the treatment of patients with NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢NAFLD confirmed by NFS score with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen etc.
- •â€¢NAFLD patients who are refractive to standard drugs of treatment.
- •â€¢Willing and able to participate in study and given written informed consent.
- •â€¢Yogya for Virechana.
排除标准
- •â€¢Excessive use of alcohol within 2 years prior to initial screening.
- •Or alcohol intake more than 20g per day for female and less than 30 g per day for males •Uncontrolled systemic disease or medically unstable and major psychological disorders •Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient •Pregnant/lactating female •Virechana ayogya.
结局指标
主要结局
1.Improvement in NAFLD Fibrosis score (Age, Hyperglycaemia, BMI, platelet Count, Albumin, aspartate aminotransferase (AST) /Serum alanine aminotransferase (ALT) ratio) along with changes in clinical presentations (relief of the following symptoms like Fatigue, indigestion, epigastric discomfort, pain abdomen, diarrhea, constipation,)
时间窗: at baseline, 60th day | and 120th day.
次要结局
- 1.Overall improvement in quality of life(2. USG Changes)