Preserved Ratio Impaired Spirometry
Conditions
Keywords
Bufei Recipe, PRISm, incidence rate
Brief summary
Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.
Detailed description
Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.
Interventions
DRUGBufei 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.
DRUGBufei 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.
Sponsors
West China Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of COPD | Change from baseline in the number of people with COPD at month 24. | Incidence rate of COPD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | Change from baseline in FEV1 at months 12 and 24. | Forced Expiratory Volume in One Second (FEV1) was mainly used for lung function evaluation |
| FEV1% pred | Change from baseline in FEV1% pred at months 12 and 24. | Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) was mainly used for lung function evaluation |
| FEV1/FVC | Change from baseline in FEV1/FVC at months 12 and 24. | Forced Expiratory Volume in One Second / Forced Vital Capacity (FEV1/FVC) was mainly used for lung function evaluation |
| IPAG-Q | Change from baseline in IPAG-Q score at months 6, 12, 18, and 24. | International Primary Airway Health Organization Questionnaire (IPAG-Q) was mainly used for chronic obstructive pulmonary screening score evaluation. |
| LFQ | Change from baseline in LFQ score at months 6, 12, 18, and 24. | Lung Function Questionnaire (LFQ) was mainly used for chronic obstructive pulmonary screening score evaluation. |
| FVC | Change from baseline in FVC at months 12 and 24. | Forced Vital Capacity (FVC) was mainly used for lung function evaluation |
| CAT | Change from baseline in CAT score at months 6, 12, 18, and 24. | Chronic Obstructive Pulmonary Disease Assessment (CAT) was mainly used for quality of life evaluation. |
| SF-36 | Change from baseline in SF-36 score at months 6, 12, 18, and 24. | Health Survey Brief (SF-36) was mainly used for quality of life evaluation. |
| Clinical symptoms | Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24. | The assessment will be done through a clinical symptom assessment questionnaire. Clinical symptoms assessed in this study include cough, sputum, wheezing, chest tightness, shortness of breath, malaise and cyanosis. Each symptom or sign will receive a score of 0-3, with higher scores indicating greater severity of the condition. |
| Biochemical indicators | Change from baseline in biochemical indicators at month 12 and 24. | Serum levels of TNF- α, IL-1, IL-6, immunoglobulin and renal connexin, prolyl peptidase, heme oxygenase-1, superoxide dismutase, glutathione peroxidase and angiotensin-converting enzyme were measured. All indicators were measured in ng/ml. |
| COPD-PS | Change from baseline in COPD-PS score at months 6, 12, 18, and 24. | Chronic Obstructive Pulmonary Disease Population Screening Questionnaire (COPD-PS) was mainly used for chronic obstructive pulmonary screening score evaluation. |
Contacts
Primary Contactyang xie
Backup Contactyang xie
Outcome results
None listed