Efficacy of topical fumigation with Yinchen Wuling powder combined with phototherapy and oral probiotics for neonatal hyperbilirubinemia: A 400-participant randomized controlled trial

Background : Neonatal hyperbilirubinemia remains one of the most prevalent neonatal disorders worldwide, as a classic traditional Chinese herbal formula for jaundice clearance, Yinchen Wuling Powder exerts choleretic and diuretic effects via external fumigation, while its synergistic therapeutic value combined with standard Western medicine protocols requires rigorous clinical verification in neonatal populations. Objective : To assess the therapeutic efficacy of Yinchen Wuling Powder herbal fumigation combined with blue light irradiation and oral live combined Bifidobacterium, Lactobacillus , and Enterococcus tablets (LCBLET) for the treatment of neonatal hyperbilirubinemia. Methods : A total of 400 neonates with jaundice admitted to the First People's Hospital of Shuangliu District, Chengdu from January 2022 to June 2024 were enrolled and randomly divided into the observation group and the control group by the random number table method, with 200 cases in each group. The control group received blue light irradiation plus oral LCBLET; on the basis of the control regimen, the observation group was additionally treated with external fumigation of Yinchen Wuling Powder. The two groups were compared in terms of overall clinical efficacy, recovery indicators (jaundice subsidence time, defecation frequency, length of hospital stay), serum bilirubin and serological parameters before and after treatment, as well as adverse reactions. This study was approved by the Institutional Ethics Committee of First People’s Hospital of Shuangliu District, Chengdu, Sichuan, China (approval No. 2020LL0101) and registered in the International Traditional Medicine Clinical Trial Registration Platform on June 12, 2026(approval No. ITMCTR2026002100). Results : The observation group achieved statistically superior comprehensive efficacy compared with the control group ( P < 0.05): the average hospital stay was shortened by 2.1 days, jaundice faded 36 hours earlier, and daily defecation frequency increased by 1.8 times. Laboratory tests revealed that the total serum bilirubin level in the observation group decreased by 24.5%, accompanied by more obvious improvements in biochemical indicators, including creatine kinase, transferrin, and lactate dehydrogenase ( P < 0.05). No drug-related adverse events were recorded during the treatment period. Conclusion : The combined therapeutic regimen can markedly alleviate clinical symptoms, accelerate rehabilitation, and improve overall therapeutic outcomes in neonates with jaundice.