Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) is a common clinical syndrome in the ICU characterized by extremely high mortality and complex pathogenesis.At present, research on individualized treatment, phenotypic differences, and therapeutic efficacy in ARDS has become a hotspot.As characterized by syndrome differentiation, traditional Chinese medicine (TCM) treatment emphasizes interindividual heterogeneity and personalized management, which is expected to serve as a breakthrough in multi-target immune regulation for ARDS. The primary objective of the study is to investigate the effect of Xuanbai Shengmai Decoction on the prognosis of patients with ARDS in a prospective randomized controlled trial. The secondary objective is to evaluate the safety of Xuanbai Shengmai Decoction in the treatment of patients with ARDS.

NCT Number	NCT07528196
Lead Sponsor	Southeast University, China Collaborators: Beijing Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Subei People's Hospital of Jiangsu Province, Wuhan Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine
Conditions	Acute Respiratory Distress Syndrome (ARDS)
Enrollment	308 participants
Start Date	2026-08-20
Primary Completion	2027-06 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-05