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

June 3, 2026 updated by: Ling Liu, Southeast University, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Patients in the control group will receive standard comprehensive Western medical treatment.
Experimental: Treatment Group
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: On day 28 of treatment
Mortality was calculated on day 28 of treatment.
On day 28 of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical scoring indicator: LIS
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Clinical scores were assessed before treatment, on day 3 of treatment, and on day 7 of treatment.
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
Serum IL-6 levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
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
The concentration of angiopoietin-2 in peripheral blood (pg/mL) will be measured at baseline (pre-treatment), Day 3, and Day 7 of treatment, as a biomarker of pulmonary vascular permeability.
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
Arterial blood gas samples will be collected at baseline (pre-treatment), Day 3, and Day 7 of treatment to determine the ratio of arterial partial pressure of oxygen (PaO₂) to the fraction of inspired oxygen (FiO₂), which will be used to assess the patient's oxygenation status.
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
The ventilator-set tidal volume (in mL) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Before treatment,on day 3 of treatment,on day 7 of treatment
Duration of mechanical ventilation
Time Frame: within 28 days
Duration of mechanical ventilation within 28 days
within 28 days
Length of ICU stay
Time Frame: within 28 days
Time of staying in ICU within 28 days
within 28 days
Multiplex detection:Pathogen Load by Multiplex PCR
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Throat swabs, fecal samples (10g), and peripheral blood (3mL) will be collected at baseline, day 3, and day 7 of treatment. Multiplex PCR will be performed to detect the nucleic acid load of target pathogens, with the unit of copies/mL, to evaluate changes in infection burden.
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
Assessed using the full APACHE Ⅱ scale at baseline (pre-treatment), Day 3, and Day 7 of treatment. The scale consists of three components: acute physiology score, age score, and chronic health evaluation score, with a total score ranging from 0 to 71. Higher scores indicate greater severity of illness and higher risk of mortality.
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
Assessed using the full Sequential Organ Failure Assessment scale at baseline (pre-treatment), day 3, and day 7 of treatment. The score evaluates the function of six organ systems: respiratory, coagulation, hepatic, cardiovascular, neurological, and renal, with a total range of 0-24. Higher scores indicate more severe organ dysfunction and a worse prognosis.
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
Static lung compliance ( mL/cmH₂O) will be calculated via the ventilator monitoring platform under constant tidal volume and plateau pressure conditions at baseline (pre-treatment), Day 3, and Day 7 of treatment, to assess respiratory mechanics function.
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
Peripheral blood samples will be collected at baseline (pre-treatment), Day 3, and Day 7 of treatment to measure serum sRAGE levels (pg/mL), which serves as a biomarker of pulmonary epithelial injury.
Before treatment,on day 3 of treatment,on day 7 of treatment
Lung injury indicator:Electrical impedance tomography (EIT) parameters of lung ventilation
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Lung ventilation distribution will be monitored by EIT at baseline (pre-treatment), Day 3, and Day 7 of treatment to assess lung injury-related indicators including lung collapse, overdistension, and ventilation inhomogeneity.
Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Pressure support (PS, cmH₂O)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
The pressure support level provided by the ventilator (in cmH₂O) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Positive end-expiratory pressure (PEEP, cmH₂O)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
The positive airway pressure maintained at the end of expiration (in cmH₂O) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Fraction of inspired oxygen (FiO₂, %)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
The fraction of inspired oxygen set on the ventilator (in %) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Before treatment,on day 3 of treatment,on day 7 of treatment
Pulmonary vascular permeability indicator: Lung ultrasound B-line score
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
The number and distribution of B-lines are assessed and scored by lung ultrasound at baseline (pre-treatment), Day 3, and Day 7 of treatment. A higher number and more diffuse distribution of B-lines indicate more severe pulmonary edema. This score is used to evaluate pulmonary vascular permeability and the severity of pulmonary edema.
Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:Tumor necrosis factor-α (TNF-α,pg/mL)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Serum TNF-α levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:C-reactive protein (CRP,mg/L)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Serum CRP levels (mg/L) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:Procalcitonin (PCT,ng/mL)
Time Frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Serum PCT levels (ng/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Before treatment,on day 3 of treatment,on day 7 of treatment
Microecology:Gut Microbiota Alpha Diversity (Shannon Index)
Time Frame: Baseline, Day 3, Day 7 of treatment
Fecal samples (10g) will be collected at baseline, day 3, and day 7 of treatment. 16S rRNA high-throughput sequencing will be performed to analyze gut microbiota alpha diversity (Shannon index, unitless) to evaluate changes in intestinal microecological homeostasis.
Baseline, Day 3, Day 7 of treatment
Metabolomics analysis:Serum Target Metabolite Concentration
Time Frame: Baseline, Day 3, Day 7 of treatment
Peripheral blood (3mL) will be collected at baseline, day 3, and day 7 of treatment. Untargeted metabolomics will be performed to detect the concentration of target serum metabolites, with the unit of μmol/L, to evaluate changes in the body's metabolic status.
Baseline, Day 3, Day 7 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southeast University, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu Province Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Guangzhou Medical University
Beijing Hospital of Traditional Chinese Medicine
Subei People's Hospital of Jiangsu Province
Wuhan Hospital of Traditional Chinese Medicine
Shenzhen Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Xuanbai Shengmai Decoction
  • 2025ZDSYLL563-P01 (Other Identifier: Zhongda Hospital Affiliated to Southeast University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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