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Not yet recruiting NCT07528196

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

Phase III Interventional Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xuanbai Shengmai Decoction.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • 28-day mortality [Time frame: On day 28 of treatment]
Secondary outcome measures (12)
  • Clinical scoring indicator: LIS [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Inflammatory indicator: Interleukin-6 (IL-6,pg/mL) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Lung injury indicator:Oxygenation index (PaO₂/FiO₂ ratio) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Ventilator parameter: Tidal volume (VT, mL) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Duration of mechanical ventilation [Time frame: within 28 days]
  • Length of ICU stay [Time frame: within 28 days]
  • Multiplex detection:Pathogen Load by Multiplex PCR [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Clinical scoring indicator:Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Clinical scoring indicators: Sequential Organ Failure Assessment (SOFA) score [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Lung injury indicator:Static lung compliance( mL/cmH₂O) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]
  • Lung injury indicator:Serum soluble receptor for advanced glycation end products (sRAGE,pg/mL) [Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07528196 · Xuanbai Shengmai Decoction · 2025ZDSYLL563-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗