Abstract
This single-center randomized controlled trial evaluated whether Chaipu Decoction used as an adjunct to Seretide improves clinical and immunological outcomes in patients with bronchial asthma. A total of 300 adults treated between January 2023 and January 2025 were randomly assigned to receive either Chaipu Decoction plus Seretide or Seretide alone for 12 weeks. Clinical efficacy, adverse reactions, Traditional Chinese Medicine (TCM) syndrome scores, pulmonary function indices (FEV1, FVC, FEV1/FVC and PEF), serum TNF-α, peripheral blood CD4+/CD8 + ratio, and Asthma Control Test (ACT) scores were assessed. The study was approved by the Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (Approval No. SDTCM-EA2023-002), and written informed consent was obtained from all participants. Patients receiving the combined treatment achieved a higher total effective rate than those receiving Seretide alone (86.7% vs. 66.7%, p < 0.05), without a significant increase in adverse reactions. Compared with the control group, the combination group showed greater reductions in TCM syndrome scores, larger improvements in lung function, a more pronounced decrease in TNF-α, and a greater increase in the CD4(+)/CD8(+) ratio after treatment, together with superior improvement in ACT scores. These findings indicate that Chaipu Decoction combined with Seretide can provide additional clinical and immunological benefit in bronchial asthma over a 12-week treatment period while maintaining acceptable short-term tolerability.