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Clinical Study on the Treatment of ARDS by Kaibi Bufei Decoction Combined with Positive Pressure Ventilation Through the Regulation of Neutrophil Extracellular Traps via the Pyrimidine Metabolic Pathway

Clinical Study on the Treatment of ARDS by Kaibi Bufei Decoction Combined with Positive Pressure Ventilation Through the Regulation of Neutrophil Extracellular Traps via the Pyrimidine Metabolic Pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000035
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Interventions

Control Group:The control group received conventional treatment, which included treating the underlying disease, anti-infective therapy, protective ventilation strategy for mechanical ventilation, mai
Experimental Group:The experimental group received conventional treatment, which included treating the underlying disease, anti-infective therapy, protective ventilation strategy for mechanical ventil

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (All four criteria must be met for inclusion): Sepsis and ARDS Diagnostic Criteria: The patient meets the diagnostic criteria for sepsis according to the 2016 International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Additionally, the patient meets the diagnostic criteria for ARDS as defined by the Berlin Definition of ARDS. Specifically, for sepsis, the Sequential Organ Failure Assessment (SOFA) score must be =2 in the presence of infection or suspected infection. For ARDS, the criteria include acute onset of symptoms within 1 week of a known clinical insult or new or worsening respiratory symptoms, bilateral opacities on chest imaging not fully explained by effusions, atelectasis, or nodules, respiratory failure not fully explained by cardiac failure or fluid overload, and a PaO2/FiO2 ratio =300 mmHg with a minimum positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) of 5 cm H2O. Traditional Chinese Medicine (TCM) Syndrome Differentiation Criteria: The patient meets the TCM syndrome differentiation criteria for "violent asthma" and "syndrome of Qi deficiency and asthma". Specifically, the patient should present with symptoms such as rapid and labored breathing, restlessness, fever, cyanosis of the lips, ecchymosis, abdominal distension, constipation, a dark purple tongue, yellow coating on the tongue, and a pulse that is deep and. Age and Gender: The patient must be older than 18 years of age, with no gender restrictions. Informed Consent: The patient or their legal guardian must be fully informed about the study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (Any one of the following criteria can lead to exclusion): Pregnancy or Lactation: Pregnant or breastfeeding individuals. Allergy to Study Medication Components: Individuals allergic to any of the herbal components of the study medication. Severe Organ Dysfunction: Individuals with severe dysfunction of vital organs such as the liver or kidneys. Acute Cardiovascular or Cerebrovascular Disease: Individuals with acute cardiovascular or cerebrovascular diseases. Hematological Disorders, Immune Deficiencies, or Malignancies: Individuals with hematological diseases, immune deficiencies, or malignancies. Long-term Use of Hormones and/or Immunosuppressants: Individuals who have been using hormones and/or immunosuppressive agents for a long period. Participation in Other Clinical Trials: Individuals who are currently or have recently participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine (TCM) Syndrome Scoring;

Secondary

MeasureTime frame
APACHE II score;SOFA score;Murray Lung Injury Score;Ventilator Parameters;PaO2/FiO2;Gut Microbiota;Long-term Prognostic Indicators;

Countries

China

Contacts

Public ContactChengjun Ban

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

13810654835@139.com13810654835

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026