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An open, randomized blank controlled, multi-clinical trial on Chuankezhi Injection in treating COPD (lung and kidney deficiency syndrome)

An open, randomized blank controlled, multi-clinical trial on Chuankezhi Injection in treating COPD (lung and kidney deficiency syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011699
Enrollment
Unknown
Registered
2017-06-19
Start date
2017-06-30
Completion date
Unknown
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstrutive Pulmonary Disease

Interventions

Treatment Group:Conventional Therapy+Chuankezhi Injection
Control Group:Conventional Therapy

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent; 2. Aged 40~80 years old, male or female; 3. Accord with diagnostic criteria for COPD at stable phase; 4. COPD patients at II~IV stage; 5. Accord with diagnostic criteria for lung and kidney dificiency syndrome in TCM.

Exclusion criteria

Exclusion criteria: 1. Be allergic to ingredients of the study medicine or allergic constitution patients; 2. Patients who need long-term hormone treatment; 3. COPD due to lacking of a1-antitrypsin, unhealthy development of lung; 4. Combined with obstructive lung diseases which have known pathogen such as pulmonary cystic fibrosis, diffuse panbronchiolitis, and blocking panbronchiolitis or have characteristic pathological feature; 5. Combined with severe primary diseases in vital organs or systems such as heart, lung, kidney, hemopoietic system; 6. ALTAST=1.5 times of upper limit of normal value, Cr> upper limit of normal value; 7. Be suspicious of or confirmed to have alcohol or drug abuse history, or other circumstances that may lower the enrollment possibility or complicate enrollment according to researchers; 8. Combined with nerve or mental diseases that make cooperation difficult; 9. Pregnant, lactating women or with family planning recently; 10. Undergoing other clinical trial or less than 3 month since the last clinical trial.

Design outcomes

Primary

MeasureTime frame
Times of COPD Acute Attack and Hospitalization;

Secondary

MeasureTime frame
TCM Syndrome;BODE Index;Life Quality;

Countries

China

Contacts

Public ContactLiu Xiaohong

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

rsclxh@gzucm.edu.cn+86 13926002208

Outcome results

None listed

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