Previously submitted to: JMIR Research Protocols (no longer under consideration since Jul 29, 2025)
Date Submitted: Jan 12, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Intervention in Disease: Study Design
ABSTRACT
Background:
Early identification and monitoring of preserved ratio impaired spirometry (PRISm) population and active intervention can reduce the incidence rate of chronic obstructive pulmonary disease (COPD) and delay the disease process. However, there is no evidence on the best treatments, and the evidence on the effectiveness and safety of pharmacological interventions is poor. Traditional Chinese medicine (TCM) has been used to treat COPD for many years.
Objective:
To clarify the clinical efficacy of Bufei granules and to establish a preventive and treatment programme for reducing the incidence of COPD with Bufei granules, so that to provide high-quality evidence-based evidence for clinical diagnosis and treatment.
Methods:
This is a multicenter, randomized, double-blind, placebo-controlled trial targeting the PRISm population. Volunteers will be randomly divided into two groups, with the experimental group receiving Bufei granules and the control group receiving placebo granules. The main outcome was the incidence rate of COPD, and the secondary outcome was lung function, COPD screening score, quality of life, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scor, biochemical indicators and economic evaluation. The plan will last for 2 years and will be followed up every 6 months.
Results:
Compared with the placebo granules group, the Bufei granules group is expected to improve lung function and quality of life of the PRISm patients, reduce dyspnea, increase exercise tolerance, delay disease progression, and reduce the incidence of COPD by approximately 40%. Data will be released upon completion of the study.
Conclusions:
The results of this study will provide valid evidence for the efficacy and safety of Bufei granules in the treatment of PRISm, resulting in a high-level TCM prevention and treatment programme to slow the progression of COPD and reduce morbidity. The programme can be promoted for use in health management departments and medical units at all levels to reduce medical expenditure and the burden of disease. Clinical Trial: ClinicalTrials.gov registration number: NCT06375824.
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