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A randomized, double-blind and controlled multi-center clinical trial of Yiqi Huatan Quyu Formula in patients with phlegm-stasis obstructive pulmonary syndrome of COPD

A randomized, double-blind and controlled multi-center clinical trial of Yiqi Huatan Quyu Formula in patients with phlegm-stasis obstructive pulmonary syndrome of COPD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068903
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2024-07-08

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

treatment group:Yiqi Huatan Quyu capsule + Western medicine
control group:Western medicine
volunteer group:no

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with COPD and stable; 2. Those who meet the classification criteria of TCM syndrome differentiation of phlegm-stasis obstructive lung syndrome; 3. Aged 40-80 years; 4. Did not participate in other clinical studies 3 months before enrollment; 5. Voluntarily receive treatment and sign informed consent; 6. No antibiotics were used 3 months before enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to the test drug or known components of the control drug; 2. Patients with extremely severe COPD and patients with acute exacerbation; 3. Pregnant and lactating patients; 4. Delirious, dementia, various mental patients; 5. Patients with cardiac function grade ? and hemodynamic instability; 6. Neuromuscular diseases affecting respiratory and motor function, such as bronchiectasis, bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pleural effusion, and malignant tumor; 7. Severe liver and kidney diseases (severe liver diseases refer to bleeding from cirrhosis, portal hypertension and varicose veins, and severe kidney diseases including dialysis and kidney transplantation); 8. Those in bed for a long time for various reasons; 9. Patients who have participated in other interventional clinical trials within the last 3 months; 10. The investigator considered it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Lung function;Number of acute exacerbations;Number of colds;

Secondary

MeasureTime frame
Chronic Obstructive Pulmonary Disease Score (CAT);Dyspnea grading;COPD-PRO Scale;Short Form Health Survey (SF-36);Self-rating Depression Scale;Self-rating Anxiety Scale;6-minute walking distance;

Countries

China

Contacts

Public ContactTong Jiabing

Anhui University of Chinese Medicine

1293603638@qq.com+86 130 6349 5956

Outcome results

None listed

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