Effectiveness of Individualized Homoeopathic Medicine in comparison with Chionanthus Virginica 6C in the treatment of non alcoholic fatty liver disease an open label randomized clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Changes in LFT parameters ALT, AST, ALP, GGT, Bilirubin, Albumin, Globulin will be assessed.
研究概览
简要总结
Non-alcoholic fatty liver disease (NAFLD) is a condition in which excessive fat accumulation builds in the form of triglycerides in the hepatocytes of liver who do not consume alcohol. The liver normally contains some fat, an individual is considered to have a fatty liver (hepatic steatosis) if the liver contains more than 5 to 10 percent fat. NAFLD has become one of the most common liver diseases worldwide, affecting approximately 25% of the global population. This is an open label, two arm, randomized clinical trial, total sample size is 62, 31 patients will be given Individualized homoeopathic medicine and other 31 patients will be given Chionanthus Virginica - 6C by using the random number chart. Aim of this study is to determine the the effectiveness of Individualized homoeopathic medicine in comparison with Chionanthus Virginica - 6C in the treatment of NAFLD. Primary objective of this study is to compare changes in Liver function test parameters and Secondary objective is to compare the changes in Ultrasonography findings and BARD SCORE. Primary outcome will be assessed by changes in Liver function test parameters at baseline, 3 months and 6 months. Secondary outcome will be assessed by changes is USG and BARD SCORE at baseline and 6 months. Total study duration is 18 months. This open label randomized clinical trial will be an attempt to explore the effects of Homoeopathy in the treatment of 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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of fatty liver of any grade as visible in USG Patient with elevated liver enzyme ALT more than 40 international unit per liter in Blood Both male and female patients aged between 20 to 70 years irrespective of all religions, and of different socioeconomic status who are willing to give written consent for participating in study and complete follow-up during study NAFLD confirmed by USG with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen who are willing to give written consent for participating in the study and complete follow up during study.
排除标准
- •Pregnant females and lactating mothers.
- •Individuals not providing written informed consent for the study.
- •Patient with evidence of liver disease other than NAFLD like alcoholic fatty liver, viral hepatitis, autoimmune liver diseases, hepatocellular carcinoma, Gilbert syndrome, Crigler Najjar syndrome, Wilson disease, Hemochromatosis etc.
- •Patient with uncontrolled diabetes, uncontrolled hypertension, renal or cardiac disease, stroke or any other serious systemic and terminal illness.
- •Patient who are taking any allopathic medicine or supplementary medicine for NAFLD.
- •There is history of significant alcohol consumption.
结局指标
主要结局
Changes in LFT parameters ALT, AST, ALP, GGT, Bilirubin, Albumin, Globulin will be assessed.
时间窗: Changes in LFT parameters ALT, AST, ALP, GGT, Bilirubin, Albumin, Globulin will be assessed at baseline, 3 months and 6 months.
次要结局
- Changes in USG will be assessed.(Changes in BARD SCORE will be assessed.)
研究者
Dr Souvik Poali
National Institute of Homoeopathy