Acute respiratory distress syndrome, ARDS
Conditions
Interventions
treatment group:basic treatment combine with Yinmajiedu Granules
control group:basic treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 yand 65 (including 18 and 65), male or female; 2. Meet the 2012 Berlin diagnostic criteria for acute respiratory distress syndrome (ARDS); 3. Meet the diagnosis of evil heat congesting the lung for traditional Chinese medicines criteria; 4. Within 48 hours of ARDS diagnosis; 5. The patients have signed the informed consent form; 6. Male subjects who agree to take effective contraceptive measures from the start of the study to 7 days after the end of treatment; female subjects of childbearing age agree to take effective contraceptive measures from the start of the study to 3 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Positive serum pregnancy test before administration in women of childbearing age, pregnant or breastfeeding women; 2. Allergic to Yinmajiedu Granules; 3. Patients with end-stage disease, expected survival < 1 week; 4. Combined with other serious heart, brain, liver and kidney dysfunction, hemodynamic instability, multiple organ failure, terminal malignant tumors and other diseases that seriously affect the prognosis; 5. Combined with the following immunosuppressive conditions: accompanied with lymphoma, leukemia or acquired immunodeficiency; received anti-tumor chemotherapy in the last 3 months, or immunosuppressive therapy due to organ transplantation, immune diseases; received allogeneic bone marrow transplantation or hematopoietic stem cell transplantation; received steroid hormone therapy in the past 3 months; 6. Subjects participated in other clinical studies (except those who did not receive intervention) within 1 month before screening, or were participating in other experimental treatment; 7. The researcher believes that it is not suitable to be included in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;Proportion of subjects with ARDS progression;The average ICU length of stay (LOS);The length of hospital stay;Change from baseline in RALE score ;Change from baseline in Murray lung injury score;Change from baseline in APACHE II score ;Change from baseline in TCM syndrome score;Change from baseline in PaO2/FiO2;Change from baseline in ESR,CRP;Change from baseline in inflammatory factor IL-1ß?IL-6?IL-8?IL-10?TNF-a; | — |
Primary
| Measure | Time frame |
|---|---|
| Ventilator-free Days ; | — |
Countries
China
Contacts
Public ContactMengying Yao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed