A Prospective Single-Arm Interventional Study To Assess The Safety And Efficacy Of Phyllanthus Niruri 6C In Patients With Grade 2 Fatty Liver

Fatty liver disease is a prevalent metabolic liver disorder characterized by excessive accumulation of fat within hepatocytes. It is broadly classified into alcoholic fatty liver disease and non-alcoholic fatty liver disease. Grade 2 fatty liver represents a moderate stage of hepatic steatosis, involving 33–66% of hepatocytes, and is clinically significant due to its potential progression to steatohepatitis, fibrosis, cirrhosis, and long-term complications such as hepatocellular carcinoma and cardiovascular disease.  Phyllanthus niruri, commonly known as Bhumi Amla, has been traditionally used for its hepatoprotective, antioxidant, and anti-inflammatory properties. In homoeopathic practice, it is known to act predominantly on the hepatobiliary system and is frequently prescribed in liver disorders. However, systematic clinical evidence evaluating the safety and therapeutic response of Phyllanthus niruri in potentised homoeopathic form, particularly in Grade 2 fatty liver disease, remains limited. This prospective, single-arm, open-label interventional study is designed to assess the safety and clinical outcomes of Phyllanthus niruri 6C in patients diagnosed with Grade 2 fatty liver disease of both alcoholic and non-alcoholic etiology. A total of 36 adult participants will be enrolled and administered Phyllanthus niruri 6C twice daily for one month, with follow-up extending up to six months. The primary outcomes focus on safety assessment through continuous monitoring of adverse drug reactions using the ADR Probability (Naranjo) Scale, along with changes in hepatic biochemical parameters, particularly alanine aminotransferase and renal function parameters as serum creatinine and urea. Secondary outcomes include changes in ultrasonographic grading of fatty liver assessed at baseline, third month, and sixth month. Data analysis will be carried out using appropriate statistical methods. Descriptive statistics will summarize baseline characteristics. For normally distributed data, paired t-tests will be applied, while non-parametric data will be analyzed using Wilcoxon signed-rank tests. McNemar’s test will be used for dichotomous outcomes related to adverse drug reactions. This study aims to generate preliminary clinical evidence regarding the safety and potential therapeutic benefits of Phyllanthus niruri 6C in Grade 2 fatty liver disease.