Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
Starting soon · Phase 3
Conditions studied: Acute Respiratory Distress Syndrome (ARDS)
In brief
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.
Key facts
- Study ID
- NCT07528196
- Run by
- Southeast University, China
- People needed
- 308
- Starts
- 2026-08-20
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Hypersensitivity to the study drugs.
- Withdrawal of treatment.
Full record on ClinicalTrials.gov
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