Clinical trial
Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial
Name
CM for Severe AECOPD
Description
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 arms
Trial start
2024-08-31
Estimated PCD
2027-04-30
Trial end
2027-10-31
Status
Not yet recruiting
Treatment
Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe
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.
Arms:
Chinese medicine granules plus western medicine treatment
Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo
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.
Arms:
Chinese medicine granules placebo plus western medicine treatment
Size
468
Primary endpoint
Treatment failure rate
During the 10 days treatment period and the 3 months follow-up period.
Eligibility criteria
Inclusion Criteria:
1. Patients with severe AECOPD.;
2. Age 40-80 years old;
3. 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;
4. Voluntarily accept the treatment and sign the informed consent form;
Exclusion Criteria:
1. Pregnant and lactating women.
2. delirious, dementia, various mental patients and other people who cannot communicate normally.
3. Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
4. Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
5. 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.
6. long-term bedridden patients for various reasons.
7. Out-of-hospital treatment for more than 3 days.
8. Participate in other drug clinical investigators within 1 month before enrollment.
9. Allergic to therapeutic drugs.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 468, 'type': 'ESTIMATED'}}
Updated at
2024-06-12
1 organization
2 products
1 indication
Organization
Henan University of Traditional Chinese MedicineProduct
Sanhan Huayin recipeIndication
COPD ExacerbationProduct
Sanhan Huayin