A multicenter, prospective, real-world study on the treatment of stable chronic obstructive pulmonary disease with Guben Kechuan granules

Phase 4

• Conditions: chronic obstructive pulmonary disease

• Registration Number: ITMCTR2024000226
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meets the diagnostic criteria of Western medicine for chronic obstructive pulmonary disease; 2. Meets the diagnostic criteria for the lung kidney deficiency syndrome of chronic obstructive pulmonary disease in traditional Chinese medicine; 3. Chronic obstructive pulmonary disease is clinically stable, with no respiratory infections or AECOPD in the past 4 weeks; 4. Aged 18-80 years old, regardless of gender; 5. Volunteer to receive treatment and sign an informed consent form.

Exclusion Criteria

1. Patients with airflow restriction caused by asthma, bronchiectasis, and pulmonary fibrosis; 2. Those who have undergone lung transplantation or pneumonectomy; 3. Patients with severe hypertension, heart failure, arrhythmia, diabetes, primary heart, liver, kidney, blood, nervous system symptoms and other poor control; 4. Lung tumors, malignant tumors (less than 5 years from initial diagnosis, or with recurrence or metastasis confirmed by imaging or tumor markers, or undergoing radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 5. Individuals who are allergic to known drug ingredients; 6. Pregnant, planned or lactating women; 7. Researchers believe that it is not suitable for inclusion in the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during the observation period;

Secondary Outcome Measures

Name	Time	Method
Severity of first AECOPD attack;Frequency of moderate/severe AECOPD during the observation period;Traditional Chinese Medicine Syndrome Score;Clinical Significant Deterioration Indicators (CID);6-minute walking distance;Respiratory difficulty score grading;Lung function indicators;Self Assessment Test;Main clinical symptom score;