Min Jie, She Bin, Zhang Xin, Mao Bing, Chen Yan
Pneumology Group, Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China.
Trials. 2019 Mar 29;20(1):187. doi: 10.1186/s13063-019-3290-y.
The common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by traditional Uighur medicine (TUM), which is widely used in Central Asia. The study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi granules in treating CCHS.
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five centers across China and randomly assigned to the high-dose group, low-dose group or placebo control group in a 1:1:1 ratio. All eligible patients will receive test drugs twice daily for 3 days. The primary outcome is the time to fever relief. Secondary outcomes include the time to fever clearance, duration of primary symptoms and each symptom and change in TUM symptom score.
This is the first placebo-controlled randomized clinical trial of a Uighur medicine in treating common cold. It will provide robust evidence on the efficacy and safety of Binafuxi granules in the treatment of CCHS.
Chinese Clinical Trial Registry, ChiCTR-IIR-17013379 . Registered on 14 November 2017.
普通感冒是一种高度流行的疾病，对社会和医疗保健有重大影响。热证感冒（CCHS）是维吾尔医学（TUM）辨证中最常见的类型之一，在中亚地区广泛应用。本研究旨在探讨比纳福西颗粒治疗CCHS的疗效、安全性及最佳治疗剂量。
这是一项多中心、随机、双盲、安慰剂对照的II期临床试验。参与者（n = 240）将从中国的五个中心招募，并以1:1:1的比例随机分配至高剂量组、低剂量组或安慰剂对照组。所有符合条件的患者将每天服用两次试验药物，持续3天。主要结局是退热时间。次要结局包括体温恢复正常时间、主要症状及各症状的持续时间以及TUM的变化。
这是第一项关于维吾尔医学治疗普通感冒的安慰剂对照随机临床试验。它将为比纳福西颗粒治疗CCHS的疗效和安全性提供有力证据。
中国临床试验注册中心，ChiCTR-IIR-17013379。于2017年11月14日注册。
