Abstract
BackgroundPostinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. However, the optimal treatment available for this condition is still not known. This study aims to investigate the efficacy and safety of a new Chinese herbal prescription, Zihua Wenfei granule (ZHWFG), in treatment of postinfectious cough (wind-cold invading lungs syndrome).MethodsThis study is a prospective, multi-center, randomized, double-blinded, parallel group, placebo-controlled trial. A total of 216 adult participants with postinfectious cough will be enrolled from six study centers across China. All participants are randomly allocated to one of three parallel treatment groups: (1) 15 g of active ZHWFG three times daily, (2) 10 g of active ZHWFG plus 5 g of ZHWFG-matched placebo three times daily, and (3) 15 g of ZHWFG-matched placebo three times daily. The treatment duration is 14 consecutive days. The primary outcomes are cough resolution rate and cough relief rate. Secondary outcomes include time to cough resolution, time to cough relief, change from baseline in cough symptom score, cough visual analog scale value, traditional Chinese medicine syndrome score at days 7 and 14, and change of CQLQ from baseline to post-treatment as well as adverse events.DiscussionThis trial may not only investigate the efficacy and safety of ZHWFG in the management of postinfectious cough (wind-cold invading lungs syndrome), but also add the evidence of Chinese herbal medicine in treatment of postinfectious cough and provide an alternative option for the management of postinfectious cough.Trial registrationChiCTR1900022078. Registered on 23 March 2019. http://www.chictr.org.cn/showproj.aspx?proj=36547.
Highlights
Postinfectious cough usually develops and persists following respiratory tract infection
Systematic reviews found that Chinese herbal medicine may alleviate the cough and improve Chinese medicine symptoms and cough-related quality of life [14, 15]
Our recently published randomized controlled trial demonstrated Qingfeng Ganke granule was effective in the treatment of postinfectious cough [16]
Summary
Postinfectious cough usually develops and persists following respiratory tract infection. The protracted cough is embarrassing and troublesome and significantly impairs daily life. Postinfectious cough usually develops and persists following respiratory tract infection, accounting for 10 to 40% cases [3, 4]. Postinfectious cough is generally self-limiting and benign; the protracted cough may become embarrassing and troublesome, even impairing daily life. In this case, patients may seek for medication therapy. Antihistamines, inhaled or oral corticosteroids, and central acting antitussive agents were used to relieve the cough, but treatment failure during tapering, relapse after drug withdrawal, and potential side effects may be faced [2]. A growing number of patients turn to complementary and alternative medicine for relieve of cough
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