Respiratory infections
Conditions
Interventions
Conventional Treatment plus Reduning Injection:None
Sponsors
The First People’s Hospital of Lianyungang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meet diagnostic criteria for acute upper respiratory infection, acute tracheobronchitis, or pulmonary infection and fulfill the definition of high-risk population. 2.Age =18 years, no gender restriction. 3.Symptom duration limits: Acute upper respiratory infection: =48 hours Acute bronchitis: =72 hours Pulmonary infection: =72 hours after diagnosis. 4.Provide informed consent with signed documentation.
Exclusion criteria
Exclusion criteria: 1.Prior use of traditional Chinese medicine (including herbal decoctions, proprietary Chinese medicines, or hospital-prepared formulations) since current illness onset. 2.Participation in any clinical trial within 1 month prior to enrollment. 3.Pregnant women, women planning pregnancy within 1 month, or lactating women. 4.Allergic constitution (e.g., history of allergy to =2 medications/foods) or known hypersensitivity to Reduning Injection or its components. 5.Deemed unsuitable for the study by the investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants Progressing to Sepsis or Septic Shock Within 14 Days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in vital signs (axillary temperature, respiratory rate, pulse, blood pressure [systolic/diastolic]);All-cause mortality within 28 days;Change from baseline in APACHE II score;Proportion of participants hospitalized within 28 days and length of hospital stay during the 28-day period.;Adverse Event (AE) / Serious Adverse Event (SAE);12-lead resting electrocardiogram (ECG) data;Change from baseline in SOFA score;Laboratory abnormalities (CBC, LFTs/RFTs, ABG, electrolytes, urinalysis) graded per CTCAE v6.0.;Change from baseline in NEWS2 score; | — |
Countries
China
Contacts
Public ContactLi Xiaomin, Xie Yongpeng
The First People’s Hospital of Lianyungang
Outcome results
None listed