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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 COPD (pattern of phlegm-heat blocking the lungs)

A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial of Qingre Bawei Capsules for the treatment of acute exacerbation of COPD (pattern of phlegm-heat blocking the lungs)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000605
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-03-20
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 Chronic Obstructive Pulmonary Disease (Phlegm-Heat Blocking the Lungs Syndrome)

Interventions

Sponsors

Kashgar City People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age between 40 and 80 years (inclusive) at the time of enrollment, regardless of gender; good verbal communication skills. (2) Weight between 45 kg and 85 kg (inclusive). (3) Diagnosed with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) according to the GOLD guidelines and requiring hospitalization, with an acute exacerbation duration of =7 days, and belonging to acute exacerbation grade I or II patients. (4) Patients with TCM syndrome differentiation as phlegm-heat blocking the lungs; patients with Mongolian medicine syndrome differentiation as hiira type. (5) The subject has given informed consent and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with heart failure asthma, bronchial asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary interstitial fibrosis, pneumothorax, pleural effusion, pulmonary embolism, neuromuscular diseases affecting respiratory function; severe acute exacerbation of COPD requiring ICU admission. (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, multiple myeloma; (5) Pregnant women or those planning to become pregnant, lactating women; (6) Patients with severe damage to heart, liver, and kidney function: cardiac function class 3-4, ALT and/or AST more than 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 Composite Index Score;

Secondary

MeasureTime frame
Chinese-Mongolian Medicine Syndrome Quantification Scoring;CAT (Chronic Obstructive Pulmonary Disease Assessment Test);Inflammatory Cytokine Testing;Modified Medical Research Council Dyspnea Scale;Sputum and serum inflammatory cytokines (IL-6, IL-8, IL-10);

Countries

China

Contacts

Public ContactMai Mai Ti Tu Sun · Yalikun

Kashi City People's Hospital

mtyalkun@126.com19370550706

Outcome results

None listed

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