About this trial
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.
Eligibility criteria
Qualifiers
Met the diagnostic criteria for ARDS according to the 2023 updated global definition.
Within 48 hours of meeting the diagnostic criteria.
Aged ≥ 18 years and ≤ 85 years.
Disqualifiers
Did not meet the diagnostic criteria.
Pregnant or lactating women.
Patients with gastrointestinal dysfunction (including gastrointestinal bleeding, severe intra-abdominal hypertension, severe intestinal obstruction, etc.), resulting in the inability to administer medication via nasogastric/nasoenteric tube or orally within 48 hours after enrollment.
SOFA score > 13.
Trial design
Treatments tested in this trial
- Xuanbai Shengmai Decoction
Treatment groups
Locations
Sponsors and collaborators
Southeast University, China
Lead sponsor
Beijing Hospital of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
Wuhan Hospital of Traditional Chinese Medicine
Collaborator
Shenzhen Hospital of Traditional Chinese Medicine
Collaborator