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Not yet recruiting NCT06375824

Bufei Recipe Reduces the Incidence Rate of COPD

No phase Interventional Preserved Ratio Impaired Spirometry

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bufei Recipe, Bufei Recipe placebo.
Who it may be relevant to
Registry conditions: Preserved Ratio Impaired Spirometry. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study

Overview

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

  • Drug 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.
  • 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.

Primary outcome measures

  • Incidence rate of COPD [Time frame: Change from baseline in the number of people with COPD at month 24.]
Secondary outcome measures (11)
  • FVC [Time frame: Change from baseline in FVC at months 12 and 24.]
  • FEV1 [Time frame: Change from baseline in FEV1 at months 12 and 24.]
  • FEV1% pred [Time frame: Change from baseline in FEV1% pred at months 12 and 24.]
  • FEV1/FVC [Time frame: Change from baseline in FEV1/FVC at months 12 and 24.]
  • IPAG-Q [Time frame: Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.]
  • LFQ [Time frame: Change from baseline in LFQ score at months 6, 12, 18, and 24.]
  • COPD-PS [Time frame: Change from baseline in COPD-PS score at months 6, 12, 18, and 24.]
  • CAT [Time frame: Change from baseline in CAT score at months 6, 12, 18, and 24.]
  • SF-36 [Time frame: Change from baseline in SF-36 score at months 6, 12, 18, and 24.]
  • Clinical symptoms [Time frame: Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.]
  • Biochemical indicators [Time frame: Change from baseline in biochemical indicators at month 12 and 24.]

Eligibility criteria

Inclusion criteria

  • 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);
  • 1 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06375824 · TCM for Pre-COPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗