The regulatory effects of Yinchen Wuling powder on chronic Hepatitis B patients with NAs by integrating network pharmacology and metabolomics: A randomized -controlled clinical study

Background CHB patients with NAs still suffer from TCM symptoms which affect the quality of life varying severity. The pathogenesis of CHB in TCM is the accumulation of damp-heat, while there are sub-types of damp heat syndrome. Objective To evaluate the clinical efficacy and safety of Yinchen Wuling powder combined with NAs on CHB patients of damp-heat and damp-predominant syndrome, while investigate the potential mechanisms and novel applications of classical prescriptions through network pharmacology combined with metabolomics. Design setting participants and intervention It was a randomized, placebo-controlled clinical study at 3 hospitals in Shanghai. A total of 62 participants diagnosed with damp-heat and damp-predominant syndrome of CHB patients with NAs were randomly allocated to receive either Yinchen Wuling powder or placebo; the therapy consisted of 8.4 g dosage, administered twice a day after meals for a duration of 4 weeks. Blood samples were collected for non-targeted metabolomics research of characteristic metabolites of CHB patients and pathways enriched by YCWLP treatment. The metabolic network and target of YCWLP on CHB patients of damp-heat and damp-predominant syndrome was constructed by the integration of network pharmacology and non-targeted metabolomics. Main outcome measures The primary outcome measures of the TCM syndrome were assessed at baseline and 4 weeks treatment with total scores of TCM Syndrome. Serum HBsAg decrease, serum HBV DNA negative rate and serum HBeAg conversion were investigated as exploratory indicators during the clinical study. Results The findings demonstrated that Yinchen Wuling powder has an effect on TCM syndrome on damp-heat and damp-predominant syndrome of CHB patients with NAs, the total efficiency rate of TCM syndrome was 61.3% in YCWLP group ( P