Clinical trial
Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study
Name
TCM for Pre-COPD
Description
Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.
Trial arms
Trial start
2024-05-01
Estimated PCD
2027-04-30
Trial end
2027-10-31
Status
Not yet recruiting
Treatment
Bufei Recipe
Bufei Recipe: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
Arms:
Bufei Recipe
Bufei Recipe placebo
The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.
Arms:
Bufei Recipe placebo
Size
1100
Primary endpoint
Incidence rate of COPD
Change from baseline in the number of people with COPD at month 24.
Eligibility criteria
Inclusion Criteria:
1. Risk factors for chronic obstructive pulmonary disease. Having one item from a, b, and c (risk factors will be further optimized based on the screening results of high-risk populations):
1. smoking history (including previous and current smokers);
2. 1 year or more of exposure to dust or chemical toxins;
3. Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
2. Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:
1. Cough (more than 3 months per year, continuous for 2 years or more);
2. Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
3. Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
3. The lung function test meets the following criteria: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 70% and FEV1 accounting for%\<80% of the expected value.
4. Meets the diagnostic criteria for lung qi deficiency syndrome.
5. Age range from 18 to 80 years old.
6. Voluntarily participate in the study and sign an informed consent form.
Exclusion Criteria:
* Pregnant and planned pregnancy, lactating women.
* Dementia and various mental illness patients.
* Other diseases with chronic cough, sputum production, or difficulty breathing.
* Merge tumors.
* Merge severe cardiovascular and cerebrovascular diseases.
* Concomitant severe liver and kidney diseases.
* Participants in clinical trials of other drugs.
* Allergies to intervention drugs.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1100, 'type': 'ESTIMATED'}}
Updated at
2024-04-19
1 organization
2 products
1 indication
Organization
Henan University of Traditional Chinese MedicineProduct
BufeiIndication
Chronic Obstructive Pulmonary DiseaseProduct
Bufei Recipe