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Randomized, placebo-controlled, double-blind, single center clinical trial of AECOPD I prescription in the treatment of acute exacerbation of chronic obstructive pulmonary disease

Clinical transformation and application of AECOPD I prescription based on pathogenesis of TCM of AECOPD with anti-inflammatory and expectorant effects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061743
Enrollment
Unknown
Registered
2022-07-02
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

acute exacerbation of chronic obstructive pulmonary disease

Interventions

Test group:Basic treatment of Western Medicine (oxygen therapy, antibiotics, bronchodilators, expectorants, hormones, noninvasive ventilation) +AECOPD I prescription granules
Control group:Basic treatment of Western Medicine (oxygen therapy, antibiotics, bronchodilators, expectorants, hormones, noninvasive ventilation) +Placebo granules

Sponsors

GuiZhou University of traditiongal Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for acute exacerbation of chronic obstructive pulmonary disease according to the guidline of GOLD in 2022; 2. Hospitalized patients by emergency department with acute exacerbation within 3 days; 3. With age between 18 and 80 years old; 4. Agree to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who require invasive mechanical ventilation; 2. Complicated with a severe tumor, unstable coronary heart disease, abnormal liver and kidney function, cerebrovascular accident, and other diseases; 3. Those with known or suspected history of alcohol or drug abuse; 4. Patients with mental disorders who are unable to actively cooperate with treatment; 5. Patients with severe intellectual or cognitive impairments; 6. Patients with a history of allergies to related drugs; 7. Those with a history of drinking in the past 7 days; 8. Those who have participated in other clinical trials within the past 3 months; 9. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Lung signs (wheezing, phlegm);Modified British medical research council(mMRC);Noninvasive oxygen saturation;—

Secondary

MeasureTime frame
outine blood test;Arterial blood gas analysis;chest X-ray or CT;Pulmonary function;Pulmonary function;The use of glucocorticoid (dose and duration);The use of antibiotics (dose and duration);length of hospital stay;Chronic Obstructive Pulmonary Disease assessment(CAT);TCM syndrome score;—

Countries

China

Contacts

Public ContactZhenghuan Li

GuiZhou University of traditiongal Chinese Medicine

2416389799@qq.com+86 18185152056

Outcome results

None listed

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