Study design
This study was designed as a randomized, superiority, assessor-blinded clinical trial with two parallel groups of intervention and control. The study protocol was reviewed and approved by the Institutional Review Board of Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, China (2018–080), and was registered on the Chinese Clinical Trial Registry (ChiCTR-1800017405). All participants provided written consent. This clinical trial adheres to the CONSORT 2010 guidelines for reporting randomized trials [