Bufei Recipe Reduces the Incidence Rate of COPD

NCT06375824 | Not Yet Recruiting DMC

• 1 other identifier: TCM for Pre-COPD
• Study Type: interventional
• Target: 1,100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Preserved Ratio Impaired Spirometry

Keywords

Bufei Recipe; PRISm; incidence rate

Outcome Measures

Primary Outcomes (1)

• Incidence rate of COPD

  Incidence rate of COPD

  Change from baseline in the number of people with COPD at month 24.

Secondary Outcomes (11)

• FVC

  Change from baseline in FVC at months 12 and 24.

• FEV1

  Change from baseline in FEV1 at months 12 and 24.

• FEV1% pred

  Change from baseline in FEV1% pred at months 12 and 24.

• FEV1/FVC

  Change from baseline in FEV1/FVC at months 12 and 24.

• IPAG-Q

  Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.

Study Arms (2)

Bufei Recipe

EXPERIMENTAL

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.

Drug: Bufei Recipe

Bufei Recipe placebo

PLACEBO COMPARATOR

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.

Drug: Bufei Recipe placebo

Interventions

Bufei Recipe 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

Bufei Recipe placebo 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.

Bufei Recipe placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• smoking history (including previous and current smokers);
• year or more of exposure to dust or chemical toxins;
• Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
• Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:
• Cough (more than 3 months per year, continuous for 2 years or more);
• Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
• Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
• 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.
• Meets the diagnostic criteria for lung qi deficiency syndrome.
• Age range from 18 to 80 years old.
• Voluntarily participate in the study and sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• West China Hospital: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Central Study Contacts

yang xie

CONTACT

0371-66248624; xieyanhn@163.com

yang xie

CONTACT

13526621325; xieyanhn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share