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

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: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Drug: Xuanbai Shengmai Decoction

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Airan Liu, PhD; Phone Number: +8615295557466; Email: airanliu@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
28-day mortality	Mortality was calculated on day 28 of treatment.	On day 28 of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical scoring indicator: LIS	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)	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)	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)	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)	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	Duration of mechanical ventilation within 28 days	within 28 days
Length of ICU stay	Time of staying in ICU within 28 days	within 28 days
Multiplex detection:Pathogen Load by Multiplex PCR	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	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	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)	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)	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	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)	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)	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, %)	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	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)	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)	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)	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)	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	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

• Sponsor: Southeast University, China
• Collaborators: 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

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Acute Respiratory Distress Syndrome (ARDS); Xuanbai Shengmai Decoction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID 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