Acute Respiratory Distress Syndrome (ARDS)Phase 3NCT07528196
Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
A Phase 3 study testing Xuanbai Shengmai Decoction in people with Acute Respiratory Distress Syndrome (ARDS), run by Southeast University, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Xuanbai Shengmai Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Xuanbai Shengmai Decoction
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Traditional Chinese Medicine, Xuanbai Shengmai Decoction
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xuanbai Shengmai Decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Mortality was calculated on day 28 of treatment.
Measured: On day 28 of treatment
Secondary outcomes (22)
Clinical scoring indicator: LIS
Clinical scores were assessed before treatment, on day 3 of treatment, and on day 7 of treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment,on day 3 of treatment,on day 7 of treatment
Duration of mechanical ventilation
Duration of mechanical ventilation within 28 days
Measured: within 28 days
Length of ICU stay
Time of staying in ICU within 28 days
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 3, Day 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start20 Aug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Subei People's Hospital of Jiangsu Province, Wuhan Hospital of Traditional Chinese Medicine, Shenzhen Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528196
- Sponsor's protocol ID
- Xuanbai Shengmai Decoction
- Other IDs
- 2025ZDSYLL563-P01
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07528196
- Acronym / sponsor ID
- Xuanbai Shengmai Decoction
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Traditional Chinese Medicine, Xuanbai Shengmai Decoction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Jiangsu Province 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 start
- 20 Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in the control group will receive standard comprehensive Western medical treatment. |
| Treatment Group | Experimental | Drug: Xuanbai Shengmai DecoctionPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanbai Shengmai DecoctionPatients 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. | Drug | Treatment Group |
Primary outcome
28-day mortality
Time frame: On day 28 of treatment
Mortality was calculated on day 28 of treatment.
22 secondary outcomes
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
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
Ventilator parameter:Pressure support (PS, cmH₂O)
Time frame: 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
Ventilator parameter:Fraction of inspired oxygen (FiO₂, %)
Time frame: 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
Inflammatory indicator:Tumor necrosis factor-α (TNF-α,pg/mL)
Time frame: 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
Inflammatory indicator:Procalcitonin (PCT,ng/mL)
Time frame: 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
Metabolomics analysis:Serum Target Metabolite Concentration
Time frame: Baseline, Day 3, Day 7 of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xuanbai Shengmai Decoction in people with Acute Respiratory Distress Syndrome (ARDS), run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Airan Liu, PhD (+8615295557466, airanliu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: On day 28 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.