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A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial of Qingre Bawei Capsules for the treatment of acute exacerbation of bronchiectasis (pattern of phlegm-heat obstruction in the lung)

A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial of Qingre Bawei Capsules for the treatment of acute exacerbation of bronchiectasis (pattern of phlegm-heat obstruction in the lung)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000472
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-06
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Bronchiectasis (Pattern of Phlegm-Heat Accumulation in the Lungs)

Interventions

Sponsors

Kashgar City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 75 years (inclusive) at the time of enrollment, regardless of gender; good verbal communication skills. (2) Diagnosed with bronchiectasis by modern medicine, with an acute exacerbation phase assessment, and acute onset within 3 days. (3) Patients with TCM syndrome differentiation of phlegm-heat blocking the lungs. (4) The subject has given informed consent and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with allergic bronchopulmonary aspergillosis, active pulmonary tuberculosis, immunodeficiency diseases, pulmonary interstitial fibrosis, pneumothorax, pleural effusion, pulmonary embolism, ciliary dysfunction, massive hemoptysis, severe cardiovascular and cerebrovascular diseases, neurological diseases, hematological diseases, and other systemic diseases; (2) Patients with TCM syndrome differentiation belonging to cold syndrome; (3) Patients with malignant tumors; (4) Patients with hematological diseases such as leukemia, aplastic anemia, myelodysplastic syndromes, thrombocytopenia, and multiple myeloma; (5) Pregnant women or those planning to become pregnant, and lactating women; (6) Patients with severe damage to heart, liver, and kidney functions: heart function class 3-4, ALT and/or AST exceeding twice the upper limit of normal, glomerular filtration rate <60%; (7) Patients with rheumatic immune diseases who need to use glucocorticoids and immunosuppressants; (8) Patients who have received systemic glucocorticoid treatment within 2 weeks or participated in other drug clinical trials within 3 months; (9) Other situations deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Sputum and Body Temperature Composite Index Scoring Table;Modified British Medical Research Council Dyspnea Scale mMRC Questionnaire Assessment Form;

Secondary

MeasureTime frame
Chinese-Mongolian Medicine Syndrome Quantification Scoring;White blood cells, neutrophil ratio, C-reactive protein (CRP), procalcitonin, blood gas analysis, inflammatory cytokine detection;Dynamic changes of chest CT;Sputum culture with drug sensitivity test;

Countries

China

Contacts

Public ContactMai Mai Ti Tu Sun Yalikun

Kashgar City People's Hospital

mtyalkun@126.com19370550706

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026