Bufei Recipe Reduces the Incidence Rate of COPD

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Preserved Ratio Impaired Spirometry

Treatments: Drug: Bufei Recipe; Drug: Bufei Recipe placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06375824

TCM for Pre-COPD

Details and patient eligibility

About

Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,100 participants in 2 patient groups, including a placebo group

Bufei Recipe

Experimental group

Description:

Bu Fei Fang: 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.

Treatment:

Drug: Bufei Recipe

Bufei Recipe placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Bufei Recipe placebo