Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China.
Department of Integrated Traditional Chinese and Western Medicine, Division of Respiratory Medicine, West China Hospital, Sichuan University, 37 Guoxue Lane, Chengdu, 610041, Sichuan Province, People's Republic of China.
Trials. 2022 May 7;23(1):373. doi: 10.1186/s13063-022-06318-5.
Approximately 5% of adults have an episode of acute bronchitis each year, accounting for more than 10 million medical visits yearly. The primary goal of treatment is reduction of symptoms. Currently, available medications are questionable in effectiveness and safety and are not recommended for routine use in clinical practice. Although Chinese herbal medicine has been widely used in the management of acute bronchitis in China, evidence-based data is lacking. This trial aims to evaluate the efficacy and safety of Tanreqing oral liquid in the treatment of acute bronchitis with phlegm-heat obstructing lungs syndrome.
METHODS/DESIGN: This study is a prospective, multi-center, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 270 acute bronchitis adult patients with phlegm-heat obstructing lungs syndrome will be enrolled from outpatients and emergency departments at nine study centers across China. All included patients will be randomly allocated to receive Tanreqing oral liquid or placebo oral liquid, 20 mL three times daily for seven consecutive days. The primary outcome will be cough resolution rate. Secondary outcomes will include change of bronchitis symptoms scores from baseline to post-treatment, cough relief rate, time to cough resolution, time to cough relief, resolution rate of a single symptom, combination medicine use, change of traditional Chinese medicine syndrome score from baseline to post-treatment, and adverse events.
This trial may provide an alternative treatment option for acute bronchitis patients, especially those in outpatients and emergency departments. It may also add evidence to Chinese herbal medicine for treating acute bronchitis.
Chinese Clinical Trial Registry ChiCTR2000040264 . Registered on 26 November 2020.
每年约有 5%的成年人会患急性支气管炎，这导致每年有超过 1000 万次的医疗就诊。治疗的主要目标是减轻症状。目前，可用的药物在疗效和安全性方面存在疑问，不建议在临床实践中常规使用。尽管中药在中国已广泛用于治疗急性支气管炎，但缺乏循证数据。本试验旨在评估痰热壅肺证急性支气管炎患者使用痰热清口服液的疗效和安全性。
方法/设计：这是一项前瞻性、多中心、随机、双盲、平行分组、安慰剂对照试验。将从中国 9 个研究中心的门诊和急诊共招募 270 名痰热壅肺证急性支气管炎成年患者。所有纳入的患者将被随机分配接受痰热清口服液或安慰剂口服液，每日 3 次，每次 20 毫升，连续 7 天。主要结局将是咳嗽缓解率。次要结局将包括治疗前后支气管炎症状评分的变化、咳嗽缓解率、咳嗽缓解时间、咳嗽缓解时间、单一症状缓解率、联合用药、治疗前后中医证候评分的变化以及不良事件。
本试验可为急性支气管炎患者，特别是门诊和急诊患者提供一种替代治疗选择。它也可能为中药治疗急性支气管炎提供证据。
中国临床试验注册中心 ChiCTR2000040264 ，于 2020 年 11 月 26 日注册。
