Acute bronchitis and acute exacerbation of chronic bronchitis
Conditions
Interventions
Treatment Group:Xixi Feining Tablet + Qinqin Baohong Zhike Capsule Simulator
Control Group:Qinqin Baohong Zhike Capsule + Xixi Feining Tablet Simulator
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Acute Bronchitis Stratum:?? (1) Meets Western medicine diagnostic criteria for acute bronchitis; (2) Meets TCM syndrome differentiation criteria for Phlegm-Heat Stagnating in Lung Syndrome; (3) Age 18~75 years old (inclusive) male or female; (4) Disease duration within 3 days; (5) Body temperature =38°C within 24 hours before consultation Bronchitis Symptom Score (BSS) =5 points; (6) Has not used cough treatment drugs before enrollment or despite prior use cough symptom score (daytime or nighttime) remains >2 points; (7) Understands and voluntarily signs the informed consent form. ??Acute Exacerbation of Chronic Bronchitis Stratum:?? (1) Meets Western medicine diagnostic criteria for acute exacerbation of chronic bronchitis; (2) Meets TCM syndrome differentiation criteria for Phlegm-Heat Stagnating in Lung Syndrome; (3) Age 18~75 years old (inclusive) male or female; (4) Disease duration within 3 days (refers only to the duration of this acute episode); (5) Body temperature =38°C within 24 hours before consultation Bronchitis Symptom Score (BSS) =5 points; (6) Has not used cough treatment drugs before enrollment or despite prior use cough symptom score (daytime or nighttime) remains >2 points; (7) Understands and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: Acute Bronchitis Stratum:?? (1) Subjects with cough symptoms caused by other respiratory diseases such as asthmatic bronchitis influenza bronchial asthma bronchiectasis suppurative tonsillitis acute infectious pharyngitis laryngitis bronchiolitis chronic pulmonary heart disease pneumonia (e.g. interstitial pneumonia) lung abscess pulmonary tuberculosis lung cancer etc.; (2) White blood cell count exceeding 20% of the upper limit of normal or neutrophil percentage exceeding 20% of the upper limit of normal; (3) Combined with severe primary diseases of the heart brain liver kidney hematopoietic systems or psychiatric disorders or immunodeficiency; (4) Alanine aminotransferase (ALT) aspartate aminotransferase (AST) >1.5 times the upper limit of normal or serum creatinine (Scr) above the upper limit of normal; (5) Known history of allergy to any component (herbal or excipient) of the trial drugs or allergic constitution; (6) Women of childbearing potential who are pregnant breastfeeding plan to become pregnant within six months or have a positive pregnancy test (urine HCG or blood HCG) or cannot take effective contraceptive measures during the trial period (required for both men and women); (7) Participation in other clinical trials within the past 1 month or currently participating in other clinical trials; (8) Investigator deems subject unsuitable to participate in this clinical trial. ??Acute Exacerbation of Chronic Bronchitis Stratum:?? (1) Subjects with cough symptoms caused by other respiratory diseases such as asthmatic bronchitis influenza bronchial asthma bronchiectasis suppurative tonsillitis acute infectious pharyngitis laryngitis bronchiolitis chronic pulmonary heart disease pneumonia (e.g. interstitial pneumonia) lung abscess pulmonary tuberculosis lung cancer etc.; (2) History of or combined with chronic obstructive pulmonary disease (COPD) or current pulmonary function test showing FEV1/FVC 1.5 times the upper limit of normal or serum creatinine (Scr) above the upper limit of normal; (6) Known history of allergy to any component (herbal or excipient) of the trial drugs or allergic constitution; (7) Women of childbearing potential who are pregnant breastfeeding plan to become pregnant within six months or have a positive pregnancy test (urine HCG or blood HCG) or cannot take effective contraceptive measures during the trial period (required for both men and women); (8) Participation in other clinical trials within the past 1 month or currently participating in other clinical trials; (9) Investigator deems subject unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall disease effective rate: Ratio of (Cured + Effective) / Total population; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Time to onset of cough relief;Cough Evaluation Test (CET);Time to cough disappearance;Quantity of rescue medication used;Effective rate of individual main symptoms and signs;Cough symptom score; | — |
Countries
china
Contacts
Public ContactZhang hong chun
China-Japan Friendship Hospital
Outcome results
None listed