A double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba Kshara and Katuki Churna along with lifestyle modifications in the management of Non-Alcoholic Fatty Liver disease(NAFLD)

This study is a double blind randomized placebo controlled clinical trial for evaluating the efficacy of Bhunimba kshara capsule, 125mg twice daily and katuki churna 1g bedtime along with modification of  lifestyle for a period of one month in the patients of Non alcoholic liver diseases. Over the past couple of decades, it has become increasingly clear that non alcoholic fatty liver disease (NAFLD) and non-alcoholic steato-hepatitis (NASH) are the significant causes of liver disease. NAFLD also called as hepatic steatosis is a manifestation of excessive triglycerides accumulation in the liver. Improper diet, lack of exercise and unhealthy lifestyle are the leading cause of this. The aim of the study to evaluate the efficacy of bhunimba kshara and katuki churna for reversing the fatty degeneration and preventing the progression of the condition to further complications like hepato cellular carcinoma and liver cirrhosis etc. The primary outcome measures the changes in the fatty degeneration of hepatic cells which will be assessed by using  ultrasonography. The secondary outcome is that the intervention will help to normalize the liver function tests and cure of the symptoms in NAFLD patients. Placebo drugs will be given the control group along with the modification of lifestyle. The subjects for the study will be selected from the OPD and IPD of All India Institute of Ayurveda , New Delhi and the follow up should be done on zero, fifteenth, thirteith and sixteith day of patient enrollement.