Bronchiectasis
Conditions
Interventions
Zhikuofang Granules Group:Oral Zhikuofang Granules
Sponsors
Guangdong Provincial Hospital ofl Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Outpatients in the age range of 18 to 75 years (including borderline values) regardless of gender; (2)With reference to the Expert consensus on the diagnosis and treatment of adult bronchiectasis in China (2021 edition) the clinical staging diagnostic criteria for acute exacerbation of bronchiectasis were met; (3)The patient's clinical symptoms were characterized by worsening of at least 2 of the 4 symptoms: cough change in sputum volume purulent sputum and hemoptysis; (4)Traditional Chinese medicine recognizes it as a syndrome of phlegm-heat congestion of the lungs and injury to both qi and yin; (5)Patients agreed to participate in this clinical trial and signed a written informed consent.
Exclusion criteria
Exclusion criteria: (1)Moderate (hemoptysis between 100 and 500 ml in 24 h) and massive hemoptysis (more than 100 ml in 1 hemoptysis or more than 500 ml in 24 h) were present during the screening period; (2)Bronchiectasis due to allergic bronchopulmonary aspergillosis non-tuberculous mycobacterial lung disease and connective tissue diseases such as rheumatoid arthritis; (3)Patients with cystic fibrosis bronchiectasis due to pulmonary fibrosis as well as those with detrusor bronchiectasis due to other diseases; (4)Patients with a combination of respiratory diseases such as chronic obstructive pulmonary disease pulmonary embolism bronchial asthma interstitial lung disease pulmonary hypertension and active tuberculosis; (5)Patients with comorbid acute or chronic respiratory failure; (6)Patients with digestive and absorption disorders or those with chronic diarrhea or loose stools; (7)Concomitant abnormal liver function [ALT or AST = 1.5 ULN (upper limits of normal)] or abnormal renal function (serum creatinine = 1.5 ULN); (8)Patients with previous comorbidities of severe cardiovascular cerebrovascular hepatic renal gastrointestinal or hematologic diseases or severe underlying diseases such as malignant tumors immunocompromised or neurological disorders; (9)Allergic individuals (allergic to two or more foods or medications) known allergy to the test drug or medicinal excipients; (10)Patients with poor compliance mental illness or other reasons for not being able to cooperate; (11)Patients who are participating in or are preparing to participate in other interventional clinical trials during the study period; (12)Pregnant or lactating women or those who plan to have children within 6 months; (13)Persons with other conditions that in the opinion of the investigator make participation in this trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall effectiveness rate (including primary and secondary conditions); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Questionnaire - Bronchiectasis;Utilization rate of hemostatic drugs;Changes in TCM evidence points;Rate of disappearance of single symptom in acute exacerbation of bronchiectasis (including primary and secondary symptoms);Change from baseline in Cough and Sputum Production Assessment Questionnaire (CASA-Q) score;Changes in VAS scores for cough and sputum; | — |
Countries
China
Contacts
Public ContactYuanbin Chen
Guangdong Provincial Hospital ofl Chinese Medicine
Outcome results
None listed