Effects of herbal medicine on clinical characteristics and biological markers in pulmonary pure ground-glass nodules: study protocol for a multicenter randomized triple-blind controlled trial.
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引用次数: 0
Abstract
Background: The widespread use of chest computed tomography (CT) screening has led to more frequent detection of pure ground-glass nodules (pGGNs). A subset of pGGNs carries a potential risk of malignant transformation. However, the current management strategy for stable pGGNs predominantly involves surveillance, with a notable absence of effective intervention strategies. Traditional Chinese medicine (TCM), as an adjunctive therapy, offers considerable promise. Preclinical studies indicate that Chuanjie Granules (CJG), a TCM compound formulation, may have potential benefits in reducing the size of pGGNs. However, there is a lack of strong evidence from large-scale randomized controlled trials. Consequently, this study aims to evaluate the clinical effectiveness and safety of CJG for pGGNs through a well-designed clinical trial and explore its mechanisms of action.
Methods: This study is a prospective, randomized, triple-blind, placebo-controlled, multicenter clinical trial designed to enroll 172 patients who have been radiologically diagnosed with pGGNs. Participants will be randomly allocated in a 1:1 ratio to receive either CJG or placebo, both with standard health education. The intervention lasts 3 months with participants receiving either CJG or a placebo, followed by a 1-year observational period after treatment. The primary outcome is the change in pGGN maximum diameter, while secondary outcomes include nodule reduction rate, density changes, malignancy risk, and patient-reported outcomes. The study will also use 16S rRNA gene sequencing and gas chromatography-mass spectrometry-based metabolomics to examine oral and gut microbiota and explore microbial-metabolic mechanisms.
Discussion: This study aims to rigorously assess the efficacy and safety of CJG and explore its mechanism of action in the intervention of pGGNs through a randomized controlled trial. Positive outcomes are anticipated to furnish the first high-quality evidence-based medical support for the use of TCM in the early intervention of pGGNs, thereby potentially enhancing clinical decision-making processes.
期刊介绍：
Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate
- the use of patient-reported outcomes under real world conditions
- the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines
- the scientific bases for guidelines and decisions from regulatory authorities
- access to medicinal products and medical devices worldwide
- addressing the grand health challenges around the world
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