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Study for the effect and mechanism of Chinese and western medicine in the treatment of infection induced acute exacerbation of COPD

Study for the effect and mechanism of Chinese and western medicine in the treatment of infection induced acute exacerbation of COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016915
Enrollment
Unknown
Registered
2018-07-03
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-09

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

Conditions

AECOPD

Interventions

Experimental group 1:XCBQT+Budesonide Suspension for inhalation (2)
Experimental group 2:XCBQT+Budesonide Suspension for inhalation (1ml)
control group:XCBQT placebo+Budesonide Suspension for inhalation (2ml)

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria of COPD; 2. The clinical grade of severity of COPD was I-II; 3. The patient has indications for antibiotic treatment(Consensus of Chinese experts on diagnosis and treatment of AECOPD (revised edition 2017)); 4. Diagnosed with Phlegm-Heat Excess Syndrome; 5. Aged 40 to 80 years old; 6. Those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with asthma, bronchiectasis, pulmonary cystic fibrosis, pulmonary fibrosis, lung cancer or other known causes and airflow limitation diseases with characteristic pathological manifestations; 2. patients with coronary heart disease, hypertensive heart disease, cardiac valve diseases and other diseases that cause labor force shortness; 3. having indications for the application of invasive mechanical ventilation; 4. patients with high clinical suspicion or diagnosis of pulmonary embolism; 5. patients with serious primary diseases of cardio-cerebrovascular, hepatic and renal hematopoietic system and endocrine system; 6. patients with intestinal obstruction requiring surgical intervention; 7. Pregnant and lactating women; 8. Mental retardation, mental retardation; 9. Liver and kidney function Scr>1.0ULN, ALT(AST) >1.5ULN; 10. People who need a combination of immunosuppressive agents; 11. Those who have used oral antibiotics for more than 3 days before screening or who have used antibiotics intravenously; 12. those who are known to be allergic to the basic therapeutic drugs; 13. those who are known to be allergic to the pharmaceutical ingredients prescribed by Chinese medicine; 14. those who have participated in or are participating in other clinical trials within the last 3 months; 15. the researcher thinks that it is inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
clinical symptoms;clinical symptoms;

Secondary

MeasureTime frame
capacity for action (mMRC);blood gas analysis;Serum inflammatory markers;Serum inflammatory markers;hospital stays;Theoretical discharge time;death rate;The proportion of patients with invasive mechanical ventilation;Proportion of patients admitted to ICU;Readmission rate within 30 days after discharge;TCM score;Clinical evaluation of TCM syndrome;

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

13701226664@139.com+86 13701226664

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026