Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Xuanbai Shengmai Decoction
DrugPatients 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 groups
308 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
28-day mortality
Mortality was calculated on day 28 of treatment.
Time frame
On day 28 of treatmentSecondary outcomes
1
Clinical scoring indicator: LIS
Clinical scores were assessed before treatment, on day 3 of treatment, and on day 7 of treatment.
Time frame
Before treatment,on day 3 of treatment,on day 7 of treatment2
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.
Time frame
Before treatment,on day 3 of treatment,on day 7 of treatment3
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.
Time frame
Before treatment,on day 3 of treatment,on day 7 of treatment4
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.
Time frame
Before treatment,on day 3 of treatment,on day 7 of treatmentLocations
Sponsors and contacts
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Southeast University, China
Lead sponsor
Beijing Hospital of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
Wuhan Hospital of Traditional Chinese Medicine
Collaborator
Shenzhen Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov
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