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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07528196). StuddyBuddy aggregates publicly available trial information.