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A multicenter, randomized, double-blind, placebo-controlled clinical trial of Xin 'an Medicine Gubenpeiyuan decoction for the efficacy and safety of COPD and its mechanism of mediating macrophage polarization to regulate lung microecology

A multicenter, randomized, double-blind, placebo-controlled clinical trial of Xin 'an Medicine Gubenpeiyuan decoction for the efficacy and safety of COPD and its mechanism of mediating macrophage polarization to regulate lung microecology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001985
Enrollment
Unknown
Registered
2025-10-22
Start date
2024-07-15
Completion date
Unknown
Last updated
2025-11-17

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:Basic treatment of Western medicine + Shenqi Tiaoshen decoction
Control group:Basic treatment of western medicine + traditional Chinese medicine simulant

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients who met the diagnostic criteria for COPD 2.It belongs to the stable phase, GOLD grade III 3.In line with the standard of TCM syndrome differentiation of lung and kidney qi deficiency syndrome 4.Age 40-80 years old 5.They did not participate in other clinical studies 3 months before enrollment 6.Antibiotics were not used 3 months before enrollment 7.Voluntary treatment, and signed informed consent

Exclusion criteria

Exclusion criteria: 1.Mild, moderate, extremely severe COPD patients and patients with acute exacerbation 2.Allergic constitution or allergies to known components of test drugs or control drugs 3.Pregnant and nursing women 4.Mentally ill, dementia, various psychiatric patients 5.Patients with cardiac function grade IV and hemodynamic instability 6.Complicated with bronchiectasis, bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pleural effusion, malignant tumor and other neuromuscular diseases affecting respiratory and motor function 7.Severe liver and kidney disease ( severe liver disease refers to cirrhosis, portal hypertension and variceal bleeding, severe kidney disease including dialysis, kidney transplantation ) 8.Long-term bedridden for various reasons 9.Those who participated in other interventional clinical trials in the past 3 months 10.Researchers believe that it is not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
The number of exacerbations and severity;

Secondary

MeasureTime frame
Dyspnea scale (MMRC);TCM clinical symptom score evaluation;Six minutes walking distance (6 MWDS);Pulmonary function;The COPD assessment test (CAT) comprehensive score;BODE index;

Countries

China

Contacts

Public ContactJiabing Tong

The First Affiliated Hospital of Anhui University of Chinese Medicine

tjbahzy@sina.com13063495956

Outcome results

None listed

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