Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial

Table 8 Outcomes and methods of analysis

Outcome/variable	Hypothesis	Measures	Methods of analysis
Baseline balance test		Quantitative outcomes (age, disease duration, body temperature, heart/respiratory rate, blood pressure)	T-test/Wilcoxon rank sum test
Baseline balance test		Qualitative outcomes (gender, marriage, race, previous treatment)	Chi-squared test/Fisher exact test/rank-sum test
Adherence at post-intervention		Percent and cases of adherence in previous 10/14 days < 80 %, > 120 % and 80 %-120 %	Chi-squared test/Fisher exact test
Concomitant treatments		Percent and cases of concomitant treatments	Chi-squared test/Fisher exact test
Intervention duration		Formula: the last day using test drugs-the first day using test drugs + 1	T-test/Wilcoxon rank sum test
Primary
Time to cough resolution	improvement occurred		Kaplan-Meier method/Log-rank test
Cough symptom score	improvement occurred		T-test/Wilcoxon rank sum test
Secondary
VAS score	improvement occurred		T-test/Wilcoxon rank sum test
TCM symptom score	improvement occurred		T-test/Wilcoxon rank sum test
TCM curative effect	improvement occurred	Percent and cases of four grades: complete recovery, excellent effect, modest effect and no effect	Cochran-Mantel-Haenszel Chi-squared test
CQLQ score	improvement occurred	Questionnaire	T-test/Wilcoxon rank sum test
Cough disappearance rate	improvement occurred		CMH Chi-squared test
Time to cough relief	improvement occurred		Kaplan-Meier method/Log-rank test

ISSN: 2662-7671