Efficacy and safety of Shufeng Huashi formula for post-infectious cough: study protocol for a randomized control...

Post-infectious cough (PIC) refers to a type of persistent cough triggered by respiratory tract infections that remains unresolved after the initial infection is controlled. It significantly impacts daily life, work, and overall quality of life. This study aims to evaluate the clinical efficacy and safety of the Shufeng Huashi (SFHS) formula, a Traditional Chinese Medicine (TCM) compound, in patients with PIC.

This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial will recruit 120 patients aged 18-65 who meet the diagnostic criteria for PIC. Participants will be randomly assigned to the SFHS group or the placebo group in a 2:1 ratio using a random coding table. The SFHS group will receive oral TCM treatment for 14 days, while the placebo group will receive a placebo for the same duration, both administered three times daily. The primary outcome measure is the cough relief rate on day 14. Secondary outcome measures include cough symptom scores (CSS), cough evaluation test (CET), TCM syndrome efficacy, Leicester Cough Questionnaire (LCQ) scores, cough cure rate, cough relief rate on day 7, time to cough cure, time to cough relief, and cough recurrence rate. Adverse events will be monitored and recorded throughout the study.

PIC is highly prevalent, yet current pharmacological treatment options remain limited. This trial is expected to generate evidence regarding the efficacy and safety of TCM in treating PIC and inform evidence-based recommendations for clinical practice.

https://itmctr.ccebtcm.org.cn/mgt/project/view/2038531670868623360, Identifier ITMCTR2025001210.