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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China

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

308 Participants
are divided into 2 treatment groups

Locations

This trial has no 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