ArticleJournal of thoracic disease2026
Efficacy and safety of Xingqin Ganke Granules in postinfectious cough: study protocol for a multicenter, randomized, double-blind, placebo-controlled, dose-ranging phase II clinical trial.
Article in Journal of thoracic disease, 2026. 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: Previous studies have demonstrated that Herbal Xingqin Ganke Granules (XQGK) exhibit significant antitussive effects across various dosage groups and ameliorate airway hyperreactivity in mice models. However, the clinical efficacy in humans warrants further investigation through additional clinical trials. The present study aims to evaluate the efficacy and safety of XQGK in the treatment of postinfectious cough (PIC) with the syndrome of latent wind-heat in the lung. Methods: This multicenter, randomized, double-blind, dose-ranging, placebo-controlled trial intends to recruit 240 patients with PIC. Subjects will be randomly assigned in a 1:1:1 ratio to either the low-dose XQGK group, the high-dose XQGK group, or the control group, with 80 patients in each group. The treatment duration will be 14 days, followed by a 3-day post-treatment follow-up. The primary efficacy outcomes include: (I) cough response rate; (II) initial cough resolution rate. The secondary efficacy outcomes include: (I) time to cough relief; (II) time to initial cough resolution; (III) sustained cough resolution duration; (IV) Leicester Cough Questionnaire (LCQ) scores; (V) Traditional Chinese Medicine (TCM) symptom score variation; (VI) TCM symptom efficacy evaluation; (VII) individual TCM symptom score variation; and (VIII) Patient Global Impression of Change (PGIC) scores. Safety endpoints will encompass the incidence of adverse events and serious adverse events, vital signs, physical examinations, laboratory biochemical indices, and 12-lead electrocardiogram findings. Discussion: This study will provide comprehensive, large-scale, multicenter clinical data on the efficacy and safety of XQGK in the treatment of PIC with the syndrome of latent wind-heat in the lung. It will contribute significant clinical evidence for the use of TCM in the management of PIC. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IPR-2400085269. Registered on 04 June 2024. https://www.chictr.org.cn/showproj.html?proj=215559.
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