Immunomodulatory effects and mechanisms of Qi-Xu-Tiao-Ti formula in Qi-deficiency constitution: a randomized controlled trial integrated with multi-omics and network pharmacology analysis
Abstract
BACKGROUND: The Qi-deficiency constitution (QDC) is a body constitution type characterized by weakened immune function and increased susceptibility to infectious diseases. Emerging evidence indicates that Chinese herbal medicine can effectively improve immunological competence in individuals with QDC. This study aims to systematically evaluate the clinical efficacy of the Qi-Xu-Tiao-Ti Formula (QXTTF) in alleviating QDC and elucidate its underlying pharmacological mechanisms through transcriptome sequencing and network pharmacology approaches.
METHODS: This single-center randomized controlled trial was performed using QXTTF to treat the QDC subjects, with Balanced constitution (BC) as the healthy controls. Primary outcome measures focused on traditional Chinese medicine constitution assessment of QDC scores, with secondary evaluation parameters including immune biomarkers (IgA and IgG levels) and adverse events monitoring. To investigate the molecular mechanisms, we performed transcriptomic profiling to identify QXTTF-responsive gene targets, followed by integrated network pharmacology analysis, molecular docking simulations to characterize the compound-target interactions underlying QXTTF's therapeutic effects, and ultimately validated at the proteomics level.
RESULTS: This study recruited 78 participants, comprising 63 QDC and 15 BC individuals. Comparative analysis between QDC and BC groups revealed significant differences in immunoglobulin IgA, IgG levels, and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 78 participants or records.
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