Acute tracheobronchitis
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Tianjin University of Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the trial, subjects must meet all of the following criteria: (1) Meet the diagnostic criteria of acute tracheobronchitis in western medicine; (2) Consistent with the syndrome differentiation criteria of phlegm-heat obstructing the lung; (3) Cough score =4 at screening; (4) The course of disease at screening =72 hours; (5) Age of 18-70 years old (including 18 and 70 years old), regardless of gender; (6) Able to understand the purpose and risks of the trial, abide by the trial procedures, and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following criteria were excluded from the trial. (1) Body temperature =37.3? at screening; (2) White blood cell count and/or neutrophil count at screening = 1.2 times the upper limit of normal value (ULN); (3) AST, ALT= 1.5 times upper limit of normal value (ULN), SCr= 1.5 times upper limit of normal value (ULN); (4) Patients who had taken other drugs for the treatment of the disease (such as antibiotics, expectorants, antitussive drugs, hormones or traditional Chinese medicine for relieving cough, resolving phlegm and asthma) within 24 hours before drug administration; (5) Combined with pulmonary infection, tuberculosis, lung cancer, bronchopneumonia, chronic obstructive pulmonary disease, bronchial asthma or other pulmonary diseases; (6) Patients with serious cardiovascular, hepatic, renal, or hematopoietic diseases who were judged by the investigators to be unsuitable for enrollment; (7) Pregnant or preparing to become pregnant or lactating women; (8) Patients suffering from mental illness or unable to cooperate with treatment; (9) Allergic constitution (allergic to more than two kinds of substances), or allergic to the test drug and its components; (10) Have participated in or are participating in other drug clinical trials within the past 1 month; (11) Suspected or real history of alcohol or drug abuse, or according to the investigator's judgment, not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Curative effect of TCM syndromes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of cough VAS;Single symptoms (cough, expectoration, wheezing, fever, thirst, chest tightness, dry stool) were improved;Cough Quality of Life Questionnaire (LCQ);Cough disappearance/basic disappearance rate;The disappearance rate of pulmonary signs (pulmonary rales);Onset time of cough relief;Area under the curve (AUC) of expectoration score versus time;Time when the cough disappears/mostly disappears;Area under curve (AUC) of cough VAS score versus time; | — |
Countries
China
Contacts
Public ContactFeng Jihong
Outcome results
None listed