MedTrace Logo

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

NCT07528196 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2026-06-05

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

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.

Sponsors & Collaborators

  • Beijing Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Subei People's Hospital of Jiangsu Province

    collaborator OTHER

  • Wuhan Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shenzhen Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Southeast University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-06-30
Completion
2027-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528196 on ClinicalTrials.gov