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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078017
Enrollment
Unknown
Registered
2023-11-27
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Sponsors

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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) Age 18-80 years old, regardless of gender; (5) Volunteer to receive treatment and sign an informed consent form.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during the observation period;

Secondary

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

Countries

China

Contacts

Public ContactZhang Wei

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

16765084@qq.com+86 158 2763 9709

Outcome results

None listed

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