Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD
1 other identifier
interventional
468
0 countries
N/A
Brief Summary
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
October 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
October 22, 2024
October 1, 2024
2.5 years
May 28, 2024
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment failure rate
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
During the 10 days treatment period and the 3 months follow-up period.
Secondary Outcomes (10)
The COPD Assessment Test(CAT)
Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
The number and severity of acute exacerbations
Within 3 months of follow-up period.
Readmission rate of acute exacerbations
Within 3 months of follow-up period.
The time to the first exacerbation of COPD
Within 3 months of follow-up period.
Dyspnea score
Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
- +5 more secondary outcomes
Study Arms (2)
Chinese medicine granules plus western medicine treatment
EXPERIMENTALOn the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
Chinese medicine granules placebo plus western medicine treatment
PLACEBO COMPARATOROn the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
Interventions
On the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
Eligibility Criteria
You may qualify if:
- Patients with severe AECOPD.;
- Age 40-80 years old;
- Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
- Voluntarily accept the treatment and sign the informed consent form;
You may not qualify if:
- Pregnant and lactating women.
- delirious, dementia, various mental patients and other people who cannot communicate normally.
- Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
- Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
- Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
- long-term bedridden patients for various reasons.
- Out-of-hospital treatment for more than 3 days.
- Participate in other drug clinical investigators within 1 month before enrollment.
- Allergic to therapeutic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henan University of Traditional Chinese Medicinelead
- Peking University Third Hospitalcollaborator
- Jiangsu Province Hospital of Traditional Chinese Medicinecollaborator
- Chengdu University of Traditional Chinese Medicinecollaborator
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicinecollaborator
- Shenzhen Hospital of Southern Medical Universitycollaborator
- Qingdao Haici Hospitalcollaborator
- Xiangyang Hospital of Traditional Chinese Medicinecollaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 12, 2024
Study Start
October 20, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
October 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share