Bronchiectasis
Conditions
Interventions
Experimental group:Orally take Qingbu Weijing Decoction, 1 dose daily, divided into 2 times.
Ingredients: 12g of Ophiopogon, 6g of Semixia, 6g of Radix Codonopsis, 10g of raw Astragalus membranaceus,
control group:Orally take Qingbu Weijing Decoction Granules Analogue (containing 5% of the active ingredients of the original formula), 1 dose daily in 2 divided doses. Duration of treatment: 6 months
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients who meet the diagnostic criteria for stable bronchiectasis in the Chinese Expert Consensus on the Diagnosis and Treatment of Bronchiectasis in Adults (2020 Edition); (2) No smoking within 1 year before enrollment, sputum >30 ml per day, and no acute exacerbation detected by history taking and physical examination; (3) Age 18-75 years (including 18 and 75 years); (4) Chinese medicine diagnosis of deficiency of qi and yin and phlegm-heat in the lungs; (5) Patients with at least 1 acute exacerbation in the past 1 year; (6) Those who are willing to comply with the physician's diagnosis, treatment arrangement and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Those who did not meet the above criteria for Western medicine diagnosis and Chinese medicine identification; patients with dry branchial dilatation with hemoptysis as the main manifestation; (2) Those who have had a change in condition within 4 weeks before enrollment: patients with combined respiratory failure, active tuberculosis, fungal infections of the lungs and other diseases; (3) Pregnant or lactating women; (4) History of chronic alcohol or drug abuse or any factor affecting adherence; (5) Patients with comorbidities of serious cardiac, cerebrovascular, hepatic, renal and hematopoietic systems, peptic ulcers and other primary diseases; (6) Abnormal liver and kidney function: those whose liver (ALT or AST) is more than double the upper limit of normal value or whose kidney function (BUN or Cr) is abnormal; (7) Patients with severe depression (HAMD total score =35), severe anxiety (SAS score =70) or psychosis; (8) Allergy and those who are allergic to this drug; (9) Those who have participated in other clinical trials within 1 month; (10) Other conditions that the investigator considers inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbations; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour sputum volume;Pulmonary function;modified Medical Research Council,mMRC;Quality of Life-Bronchiectasis, QOL-B;Abundance and diversity of airway microbiome;Time to first acute exacerbation;Specific gravity of dry/wet sputum;Chinese Medicine Criteria Score;Chest CT;Mucin indicators: MUC5AC,MUC5B,MUC2,MUC4;Inflammatory marker: IL-8, IL-1ß, TNF-a, neutrophil elastase; | — |
Countries
China
Contacts
Public ContactQing Miao
National Health Commission (NHSC)
Outcome results
None listed