# Efficacy and safety of Galgeun-tang-ga-cheongung-sinyi for nasal congestion with common cold: A study protocol for randomized, double-blind, placebo-controlled, parallel, multicenter clinical trial

## TL;DR

This study aims to evaluate the effectiveness and safety of an herbal formula for treating nasal congestion caused by the common cold.

## Contribution

The study introduces a clinical trial protocol for an herbal treatment as an alternative to conventional cold medications.

## Key findings

- The trial will assess symptom improvement and quality of life using the WURSS-21-K questionnaire.
- Safety will be evaluated through adverse effects and clinical tests.
- Results may support the clinical use of herbal medicine for common cold symptoms.

## Abstract

Common cold is a common respiratory disease caused by a viral infection of the upper respiratory tract, leading to various symptoms including cough, sneezing, nasal congestion, and sore throat. As the medications used to treat the common cold may cause adverse effects such as gastrointestinal symptoms, drowsiness, and decreased concentration, it is necessary to explore alternative treatments for patients with the common cold. The aim of this study is to assess the effectiveness and safety of Galgeun-tang-ga-cheongung-sinyi (GGTCS), an herbal formula used to treat respiratory diseases, as an alternative medicine for nasal congestion with common cold.

This is a randomized, double-blind, placebo-controlled, parallel, multicenter clinical trial. A total of 176 participants will be recruited and randomly allocated to the GGTCS group and control (placebo) group in a 1:1 allocation ratio. GGTCS or placebo will be administered three times per day for 7 days. The participants will be instructed to discontinue the medicine if the symptoms of the common cold disappear within 7 days of the treatment period and return the remaining medicine to the investigators. The primary outcome measures are changes in the total score of the Wisconsin Upper Respiratory Symptom Survey-21-Korean version (WURSS-21-K) (symptom score + quality of life score) on day 7 compared with baseline. Secondary outcome measures include the total, symptom, and quality of life scores of the WURSS-21-K, nasal congestion severity score, nasal and systemic symptom score visual analogue scale (VAS), duration of common cold symptoms, recovery from common cold, global evaluation of efficacy, and 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L). The exploratory outcome measure is a questionnaire for common cold pattern identification (QCCPI), and the safety assessment factors include adverse effects, vital signs, electrocardiograms, and clinical laboratory tests.

The goal of this study is to assess the effectiveness and safety of GGTCS for nasal congestion with the common cold and the clinical use of herbal medicine. The results are expected to help researchers design further clinical trials using herbal medicines to treat the common cold.

This trial was registered on February 28, 2025 at the National Clinical Trial Registry Clinical Research Information Service (https://cris.nih.go.kr) with the identifier number KCT0010251.