Acute exacerbation of chronic bronchitis
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 attack of chronic bronchitis; (2) Consistent with the syndrome differentiation criteria of phlegm-heat obstructing the lung; (3) Cough score =4 at screening; (4) Age of 18-70 years old (including 18 and 70 years old), regardless of gender; (5) 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) Persistent airflow limitation at screening with FEV1/FVC < 70%; (2) AST, ALT= 1.5 times the upper limit of normal value (ULN), SCr= 1.5 times the upper limit of normal value (ULN); (3) Use of anticholinergic or glucocorticoid drugs within half a month before onset, or patients who had taken other drugs for the treatment of the disease (such as antibiotics, expectorants, antitussive agents, systemic or inhaled hormones, and inhaled bronchodilators or antitussive, expectorant and asthmatic traditional Chinese medicine) within 24 hours before the drug administration were enrolled. (4) Combined with chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, new or still need treatment of pulmonary tuberculosis or lung cancer,inflammation,lung abscess and other lung diseases; (5) Patients with serious cardiovascular, hepatic, renal, or hematopoietic diseases who were judged by the investigators to be unsuitable for enrollment; (6) Pregnant or preparing to become pregnant or lactating women; (7) Patients suffering from mental illness or unable to cooperate with treatment; (8) Allergic constitution (allergic to more than two types of substances), or allergic to the test drug and its components, cephalosporins,people with substance allergy; (9) Patients who have participated in or are participating in other drug clinical trials within the past 1 month; (10) 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;Single symptoms (cough, expectoration, wheezing, fever, thirst, chest tightness, dry stool) were improved;Cough Quality of Life Questionnaire (LCQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of cough VAS;Time when the cough disappears/mostly disappears;Cough disappearance/basic disappearance rate;Onset time of cough relief;Area under curve (AUC) of cough VAS score versus time;Area under the curve (AUC) of expectoration score versus time;The disappearance rate of pulmonary signs (pulmonary rales); | — |
Countries
China
Contacts
Public ContactFeng Jihong
The Second Affiliated Hospital of Tianjin University of Chinese Medicine
Outcome results
None listed