Efficacy of Sharapunkhadi powder (a polyherbal formulation) and lifestyle modification in the management of nonalcoholic fatty liver disease-A randomized placebo-controlled clinical trial.

Background: Nonalcoholic fatty liver disease (NAFLD) is an expanding health problem, which varies in prevalence among ethnic groups, occurring with an estimated global prevalence of 25%. In high-risk populations, the prevalence of NAFLD may be as high as 70%-90%. No established pharmacological treatment is available for NAFLD in modern medicine and hence, there is a search for alternative treatment modalities in other systems of medicine, which is safe and cost-effective.

Aim: The aim is to evaluate the efficacy of Sharapunkhadi powder and lifestyle modification in the management of NAFLD.

Materials and methods: Patients suffering from any of the components of metabolic syndrome, i.e. hypertension, diabetes mellitus, hypertriglyceridemia, elevated body mass index (>25 kg/m²), truncal obesity, or presenting with the symptoms of indigestion, abdominal discomfort, flatulence. were screened with liver function tests and ultrasonography (USG) of the abdomen. A total of 93 patients confirmed with fatty liver Grade 1-3 were selected for the present trial and were randomly divided into two groups. After Mridu Virechana (mild purgation) with Haritaki powder (6-8 g) according to Koshtha, in group A (n = 46), 2 capsules (500 mg each) filled with Sharapunkhadi powder thrice a day before food with warm water along with lifestyle modification were administered for 8 weeks. In group B (n = 47), capsules filled with roasted Sooji powder in the same dose as mentioned for group A was given along with lifestyle modification and were maintained as a placebo. Relief in subjective parameters such as indigestion, abdominal discomfort, and flatulence and improvement in the grades of fatty liver evident from USG was considered for the overall assessment of the therapy in both the groups. SigmaStat 3.1 software was used for statistical calculation. Wilcoxon signed-rank test for subjective criteria and Student's paired t-test for objective criteria were applied to check the level of significance in a single group before and after treatment, while Student's unpaired t-test for objective criteria was applied to assess the level of significance of difference observed between two groups.

Results: After 8 weeks of treatment, it was found from USG findings that there was a statistically significant improvement by about 39.25% in group A and 31.82% in group B, in the grade of fatty liver. The combination of Sharapunkhadi powder along with lifestyle modification provided comparatively better relief in subjective and objective parameters over the placebo control group.

Conclusion: Sharapunkhadi powder is a promising herbal preparation for the management of NAFLD and the combination of Sharapunkhadi powder along with lifestyle modification can yield more significant results in the management of NAFLD than lifestyle modification alone.