ArticleFrontiers in medicine2025
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.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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. Clinical trial registration: http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025001413.
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