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A Study on the Application of Integrated Traditional Chinese and Western Medicine Protocol with Shenling Bufeitongluo Decoction in the Prevention and Treatment of Frequent Acute Exacerbations in Patients with Stable Chronic Obstructive Pulmonary Disease

A Study on the Application of Integrated Traditional Chinese and Western Medicine Protocol with Shenling Bufeitongluo Decoction in the Prevention and Treatment of Frequent Acute Exacerbations in Patients with Stable Chronic Obstructive Pulmonary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001615
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

chronic obstructive pulmonary disease

Interventions

experimental group:Health education + dual/triple drug inhalation therapy + traditional Chinese medicine granules
control group:Health education + dual/triple drug inhalation therapy + placebo of traditional Chinese medicine

Sponsors

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with stable chronic obstructive pulmonary disease (COPD); (2) Patients with stable COPD who have frequent acute exacerbations; (3) Meeting the diagnostic criteria for lung qi deficiency syndrome or lung-spleen qi deficiency syndrome in traditional Chinese medicine; (4) Age range: 40 years = age < 80 years, gender unrestricted; (5) Undergoing a 2-week washout period before enrollment; (6) Voluntary participants with good compliance and having signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with other respiratory system diseases such as respiratory tract infection, bronchiectasis, bronchial asthma, interstitial lung disease, and eosinophilic lung disease, etc. (2) Patients allergic to the ingredients of the formula. (3) Patients with concurrent malignant tumors, heart failure, arrhythmia, neurological diseases, hematological diseases, mental illness, or severe liver and kidney dysfunction. (4) Pregnant or lactating women. (5) Patients who are unable to complete pulmonary function tests, blood tests, and questionnaires for scoring. (6) Patients who have participated in other drug clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
The number of acute exacerbations within one year;

Secondary

MeasureTime frame
quality of life;lung function;BODE index;6-minute walk test distance;Clinical symptoms and signs;Shortness of Breath Questionnaire;

Countries

China

Contacts

Public ContactLijian Pang

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

hahaya123@126.com18004010055

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026