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Protocol for a series of single-case randomized controlled trials on the safety and efficacy of concentrates growth factor for the treatment of chronic obstructive pulmonary disease

Protocol for a series of single-case randomized controlled trials on the safety and efficacy of concentrates growth factor for the treatment of chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063268
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-12
Completion date
Unknown
Last updated
2023-04-17

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

control group:normal saline

Sponsors

Xiangyang First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria for COPD; 2. Aged 18-75 years; 3. BMI <= 30 kg/m2; 4. Airflow limitation grading II-III (mMRC grading) in patients with stable COPD; 5. History of exposure to risk factors for chronic obstructive pulmonary disease and currently away from exposure factors; 6. In a stable phase, free of respiratory infections and acute exacerbations in the last 4 weeks; 7. History of at least 2 acute exacerbations or 1 hospitalization for acute exacerbations in the last 12 months.

Exclusion criteria

Exclusion criteria: 1. Concomitant significant hemoptysis; 2. Other concomitant active or clinically significant respiratory disease with significant study impact; 3. Previous pneumonectomy or lung decompression within 12 months prior to screening; 4. Within 1 month of screening, enrolled or planning to enroll in a pulmonary disease rehabilitation program; 5. Current regulated use of oral glucocorticoids; 6. Patients with associated malignancies; 7. With severe cardiac, hepatic, or renal system disease; 8. Pregnant or lactating women, or women planning to become pregnant during the study period; 9. Unable to communicate normally and incapacitated, making it difficult to assess the effectiveness and safety of the treatment; 10. In the opinion of the investigator, unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Pulmonary Function Tests;

Secondary

MeasureTime frame
CT of the chest;St.George's Respiratory Questionnaire;EuroQol five-dimensional questionaire;COPD self-assessment test;6 minute walking test;modified British medical research council;Acute exacerbation of chronic obstructive pulmonary disease;

Countries

China

Contacts

Public ContactBin Pei

Xiangyang First People's Hospital

xyxzyxzx@163.com+86 1895678520

Outcome results

None listed

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