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A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of Chronic Obstructive Pulmonary Disease (COPD) treated with Chronic Obstructive Pulmonary Disease (COPD) granules in the acute exacerbation phase (phlegm heat obstructing lung syndrome).

A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of Chronic Obstructive Pulmonary Disease (COPD) treated with Chronic Obstructive Pulmonary Disease (COPD) granules in the acute exacerbation phase (phlegm heat obstructing lung syndrome).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002402
Enrollment
Unknown
Registered
2025-12-06
Start date
2024-07-02
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Chronic obstructive pulmonary disease - acute exacerbation phase

Interventions

experimental group:Basic treatment+Manzhu Feishu granules
control group:Basic treatment+Manzhu Feishu granules placebo

Sponsors

Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 and above, gender not limited; (2) Those who meet the diagnostic criteria for AECOPD in the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Revised in 2023) and have a severity level of AECOPD classified as Grade I or II; (3) Meets the diagnostic criteria for phlegm heat obstructing the lungs in traditional Chinese medicine; (4) Co infected individuals (hs CRP>10mg/L); And 1): worsening of breathing difficulties, increased sputum volume, and purulent sputum, or 2): only two of these symptoms appear, but including purulent sputum. (5) Patients who voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Major lung diseases other than COPD, such as active tuberculosis, fungal infection, tumor, bronchial asthma, bronchiectasis with infection, pulmonary fibrosis and other primary lung diseases; (2) Combined with severe cardiovascular disease (congestive heart failure, classified as NYHA severity level IV); Significant arrhythmias or heart valve abnormalities that affect hemodynamic status; History of unstable angina or myocardial infarction within the past 6 months; (3) For patients with severe primary diseases of the heart, liver, kidney, digestive, and hematopoietic systems, liver function ALT/AST is greater than twice the upper limit of normal, and renal function SCr is greater than the upper limit of normal; (4) Severe ventilation dysfunction requiring invasive mechanical ventilation; (5) Diabetes ketoacidosis, diabetes hyperosmolar coma; (6) Pregnant or lactating women; (7) Individuals with allergic constitution or those who are allergic to known ingredients of this medicine; (8) Patients with mental illness and others who are unable to provide sufficient informed consent due to intellectual or behavioral impairments; (9) Participated in other clinical trials within the previous month prior to screening; (10) The researchers believe that there are other factors that are not suitable for inclusion, or those who are currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine Syndrome Efficacy;

Secondary

MeasureTime frame
Traditional Chinese Medicine Single Symptom Score;pulmonary function;Inflammatory markers (hs CRP);Modified Medical Research Council Dyspnea Scale;6-minute walking test;

Countries

CHINA

Contacts

Public ContactTAN GUANG BO

HUNAN ACADEMY OF CHINESE MEDICINE

tgb989@126.com13873171912

Outcome results

None listed

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