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NOT YET RECRUITING
NCT07528196
PHASE3

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

Sponsor: Southeast University, China

View on ClinicalTrials.gov

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.

Official title: Clinical Collaboration Project of Integrated Traditional Chinese and Western Medicine for Major and Intractable Diseases - A Multicenter, Randomized Controlled Trial of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2026-08-20

Completion Date

2027-12

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DRUG

Xuanbai Shengmai Decoction

Patients in the treatment group will receive Xuanbai Shengmai Decoction orally or via nasogastric gavage on the basis of standard comprehensive Western medical treatment. The decoction will be administered within 24 hours after enrollment, one dose per day in two divided administrations, for a total of 7 days.