NCT07528196

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
19mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 14, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

March 20, 2026

Last Update Submit

April 9, 2026

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute Respiratory Distress Syndrome (ARDS)Traditional Chinese MedicineXuanbai Shengmai Decoction

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Mortality was calculated on day 28 of treatment.

    On day 28 of treatment

Secondary Outcomes (22)

  • Clinical scoring indicator: LIS

    Before treatment,on day 3 of treatment,on day 7 of treatment

  • Inflammatory indicator: Interleukin-6 (IL-6,pg/mL)

    Before treatment,on day 3 of treatment,on day 7 of treatment

  • Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL)

    Before treatment,on day 3 of treatment,on day 7 of treatment

  • Lung injury indicator:Oxygenation index (PaO₂/FiO₂ ratio)

    Before treatment,on day 3 of treatment,on day 7 of treatment

  • Ventilator parameter: Tidal volume (VT, mL)

    Before treatment,on day 3 of treatment,on day 7 of treatment

  • +17 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Patients in the control group will receive standard comprehensive Western medical treatment.

Treatment Group

EXPERIMENTAL

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

Drug: Xuanbai Shengmai Decoction

Interventions

Xuanbai Shengmai DecoctionDRUG

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.

Treatment Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Airan Liu, PhD

CONTACT

+8615295557466airanliu@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 14, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-02