Jiang Hong-li, She Bin, Liu Wei, Mao Bing, Zhang Ju-ying
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, No. 37 Guoxue Street, Chengdu, 610041, Sichuan Province, China.
Department of Epidemiology and Biostatistics, School of Public Health, Sichuan University, No. 16 People's South Road, Chengdu, 610041, Sichuan Province, China.
Trials. 2016 Feb 19;17:99. doi: 10.1186/s13063-016-1217-4.
Acute pharyngitis accounts for an estimated 15 million patient visits in the United States. However, there is no proven effective and safe treatment. Although Chinese herbal medicine is widely used in the treatment of acute pharyngitis, there is a lack of evidence-based data. Despite several clinical trials conducted in this setting, no randomized placebo-controlled trial has been performed to date. This trial aims to investigate the efficacy and safety of Qi-Wei-Qing-Yan aerosol (QWQYA), a Chinese herbal prescription, compared with a placebo aerosol in the treatment of acute pharyngitis with lung-stomach excess-heat syndrome.
METHODS/DESIGN: This is a prospective, multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 420 adult patients, of either sex, with acute pharyngitis will be enrolled from seven study sites across China. All patients will be randomly allocated to one of three parallel treatment groups: (1) QWQYA with the current propellant, (2) QWQYA with a previous propellant, and (3) the placebo aerosol with the current propellant. The study medication will be administered into the pharyngeal region in three sprays thrice daily for 5 consecutive days. The primary outcome measures are time to complete resolution of sore throat and relief rate of sore throat. Secondary outcome measures include resolution rate of sore throat, time to relief of sore throat, intensity of sore throat, and change of traditional Chinese medicine syndrome score and clinical signs score from baseline to post-treatment, as well as the occurrence of any adverse events.
This will be the first clinical trial to investigate the efficacy and safety of QWQYA in the treatment of acute pharyngitis in an adult population in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it establish the basis for the efficacy and safety of QWQYA in treating acute pharyngitis, but it might also provide evidence to support the use of Chinese herbal medicine in treating acute pharyngitis and thus support an alternative treatment option for management of acute pharyngitis.
Chinese Clinical Trial Registry ChiCTR-IPR-15005991.
在美国，估计每年有1500万人次因急性咽炎就诊。然而，目前尚无经证实的有效且安全的治疗方法。尽管中草药广泛用于急性咽炎的治疗，但缺乏循证数据。尽管在此领域已开展了多项临床试验，但迄今为止尚未进行随机安慰剂对照试验。本试验旨在研究中药制剂七味清咽气雾剂（QWQYA）与安慰剂气雾剂相比，治疗肺胃实热证急性咽炎的疗效和安全性。
方法/设计：这是一项前瞻性、多中心、随机、双盲、平行组、安慰剂对照试验。将从中国7个研究地点招募总共420例成年急性咽炎患者，不限性别。所有患者将被随机分配到三个平行治疗组之一：（1）使用现用抛射剂的QWQYA组；（2）使用既往抛射剂的QWQYA组；（3）使用现用抛射剂的安慰剂气雾剂组。研究药物将通过每日三次、每次三喷的方式喷入咽部，连续用药5天。主要结局指标为咽痛完全缓解时间和咽痛缓解率。次要结局指标包括咽痛消退率、咽痛缓解时间、咽痛程度、从基线到治疗后中医证候评分和临床体征评分的变化，以及任何不良事件的发生情况。
这将是第一项以多中心、随机、双盲、平行组、安慰剂对照方式研究QWQYA治疗成年急性咽炎疗效和安全性的临床试验。它不仅可能为QWQYA治疗急性咽炎的疗效和安全性奠定基础，还可能为支持中草药用于治疗急性咽炎提供证据，从而为急性咽炎的管理提供一种替代治疗选择。
中国临床试验注册中心ChiCTR-IPR-15005991
