Bufei Recipe Reduces the Incidence Rate of COPD

NCT ID: NCT06375824

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-10-31

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.

Conditions

Preserved Ratio Impaired Spirometry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bufei Recipe

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.

Group Type: EXPERIMENTAL

Bufei Recipe

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Bufei Recipe placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

yang xie

Role: CONTACT

xieyanhn@163.com

0371-66248624

yang xie

Role: CONTACT

xieyanhn@163.com

13526621325

Other Identifiers

TCM for Pre-COPD

Identifier Type: -

Identifier Source: org_study_id