Study design
This was a parallel-group, randomized, double-blind, controlled trial. Ethical approval for this study (HEC-KYJJ-2021-145-01) was provided by the Institutional Review Board of Yichang Central People’s Hospital, Wujiagang District, Yichang City, Hubei Province (contact: Yan Kejun) on January 7, 2022. The trial was registered on January 15, 2022 in the Chinese Clinical Trial Registry (