[Translation] A randomized, double-blind, very low-dose parallel-controlled, multicenter, phase III clinical trial of Qingke Pingchuan granules in the treatment of acute bronchitis in children (phlegm-heat stagnation in the lungs).
主要目的:以极低剂量试验药物为对照,评价清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的有效性和安全性。
次要目的:以极低剂量试验药物为对照,评价清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)患者在缓解支气管炎病情/症状体征、改善中医证候作用。
[Translation] Primary purpose: To evaluate the efficacy and safety of Qingke Pingchuan granules in treating acute bronchitis (phlegm-heat stagnation in the lungs) in children, using very low doses of test drugs as controls.
Secondary purpose: To evaluate the efficacy of Qingke Pingchuan granules in treating acute bronchitis (phlegm-heat stagnation in the lungs) in children, using very low doses of test drugs as controls, in relieving the condition/symptoms and signs of bronchitis and improving TCM syndromes.