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NCT07528196
Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 308
Sponsor: Southeast University, China
Summary
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
Inclusion Criteria:
1. Met the diagnostic criteria for ARDS according to the 2023 updated global definition.
2. Within 48 hours of meeting the diagnostic criteria.
3. Aged ≥ 18 years and ≤ 85 years.
Exclusion Criteria:
1. Did not meet the diagnostic criteria.
2. Pregnant or lactating women.
3. 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.
4. SOFA score \> 13.
5. Hypersensitivity to the study drugs.
6. Withdrawal of treatment.
Source: ClinicalTrials.gov (NCT07528196). StuddyBuddy aggregates publicly available trial information.