Efficacy and Safety of Susu Xiao`er Zhike Granules for Treating Acute Cough Due to Common Cold in Children: A Chinese Patent Medicine Study Protocol for Randomized Controlled Trial

Abstract

\n Background: Cough is the most bothersome symptom, while more than two-thirds of children with common cold have to endure it for weeks. Susu xiao`er zhike granules (Susu) which used to be a clinical experienced herb formula for treating cough caused by common cold, is reproduced into a patent medicine for meeting market demands as a new drug. This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children. Methods/design: This is a protocol for a randomized, double-blind, dose exploration, multicenter clinical trial. A total of 240 children aged 6-14 years old (<14y) with acute cough caused by common cold will be randomly assigned to one of three groups, respectively take Susu of high dose (double-dose), medium dose (recommended dose) and very low dose (5% recommended dose) for 5 days. The primary outcome is clinical cure time of cough. Secondary outcomes will include clinical cure rate, onset time, AUC of cough severity VAS score-time, PAC-QoL, PGA, cure rate of symptoms and efficacy of traditional Chinese syndrome. For safety assessment, adverse events, laboratory tests and vital signs will be observed. Participants will complete the trial after 1-day follow up assessment. We collect the main data from subject diary. Discussion: The study is a phase II clinical trial that will evaluate the efficacy of a Chinese patent medicine in the treatment of cough in children.Trial registration: Chinese clinical trial registry, ChiCTR1900028377. Registered 20 December 2019, http://www.chictr.org.cn/showproj.aspx?proj=46643