Acute bronchitis
Conditions
Interventions
High-dose experimental group:Jin Zhen Oral Liquid, 3 vials (30ml) per dose, three times daily, by mouth.
Low-dose treatment group:66.7% concentration of Jinzhen Oral Liquid, 3 vials (30ml) per dose, three times daily, oral administration.
Placebo control group:Jin Zhen Oral Liquid Simulator, 3 vials (30ml) per dose, 3 times daily, oral administration.
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who meet the diagnostic criteria for acute bronchitis in Western medicine; 2. Those who meet the diagnostic criteria for the pattern of phlegm-heat obstructing the lungs in traditional Chinese medicine; 3. Aged between 15 and 65 years (inclusive); 4. The highest body temperature before the visit was <38°C, and the cough symptom score (daytime plus nighttime score) was =4 points; 5. The duration of illness was =48 hours, and no antibiotics, antitussive, or expectorant drugs (including both traditional Chinese and Western medicine) that may affect acute bronchitis were used before the visit; 6. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Cases where severe bronchitis and early pneumonia are difficult to differentiate; 2. Patients with COVID-19 infection, influenza, and other acute infectious diseases; 3. Patients withacute upper respiratory tract infections, bronchiectasis, pneumonia, bronchopneumonia, capillary bronchitis-associated pneumonia, suppurative tonsillitis, asthmatic bronchitis, bronchial asthma (including cough-variant asthma), lung abscess, tuberculosis, or tumors; 4. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or patients with mental illness; 5. Patients with a history of allergies or hypersensitivity to known components of the investigational drug; 6. Patients with suspected or confirmed history of alcohol or substance abuse; 7. White blood cell count =10.0×10^9/L, neutrophil ratio =75%; 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal, serum creatinine (Cr) >upper limit of normal; 9. Pregnant or breastfeeding women, and female subjects with plans to become pregnant within the next 1 month; 10. Subjects who have participated in other clinical studies within the past 1 month prior to screening; 11. Subjects deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough Cessation Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| cough suppressant time to effectiveness;Cough resolution rate, sputum resolution rate, lung crackles resolution rate;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Change in total score of the Bronchitis-specific symptom and sign scoring scale (BSS scale) from baseline.;Clinical cure rate;The decrease values of each item score and disappearance rate in the Cough Severity Evaluation Table (CET);The number and proportion of antipyretic analgesics used during treatment.; | — |
Countries
China
Contacts
Public ContactZhang Lishan
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed