Efficacy, Safety and Economic Evaluation of Wolbigachul-Tang for Chronic Cough Due to Upper Airway Cough Syndrome (UACS): A Study Protocol for Randomized, Double-Blind, Active-Comparator Controlled, Parallel, Exploratory Clinical Trial

Upper airway cough syndrome (UACS) is a common cause of chronic cough characterized by upper airway symptoms, including nasal discharge and throat discomfort. Empirical treatments for UASC-induced chronic cough, such as first-generation antihistamines, have been used; however, the long-term use of t...

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Veröffentlicht in:Healthcare (Basel) 2023-10, Vol.11 (20), p.2733
Hauptverfasser: Woo, Seong-Cheon, Lyu, Yee Ran, Lee, Su Won, Kwon, O-Jin, Choi, Young-Eun, Yang, Changsop, Park, Yang Chun
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container_title Healthcare (Basel)
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creator Woo, Seong-Cheon
Lyu, Yee Ran
Lee, Su Won
Kwon, O-Jin
Choi, Young-Eun
Yang, Changsop
Park, Yang Chun
description Upper airway cough syndrome (UACS) is a common cause of chronic cough characterized by upper airway symptoms, including nasal discharge and throat discomfort. Empirical treatments for UASC-induced chronic cough, such as first-generation antihistamines, have been used; however, the long-term use of these medicines has adverse effects. Therefore, we evaluate the efficacy, safety, and economic feasibility of Wolbigachul-tang (WBGCT), an herbal medication for UASC-induced chronic cough. This is a randomized, double-blind, active-comparator-controlled, parallel, and exploratory clinical trial. Thirty patients with UASC-induced chronic cough will be recruited and randomly allocated to the WBGCT and control groups in a 1:1 allocation ratio. The investigational medicine will be administered three times per day for 2 weeks (3 g of WBGCT at a time). The primary outcome measure is the cough symptom score measured at screening, before starting the trial, and after 2 and 4 weeks. Secondary outcome measures include the cough visual analog scale, nasal discharge score, questionnaire of clinical symptoms of cough and sputum, Leicester cough questionnaire-Korean version, integrative medicine outcome scale, integrative medicine patient satisfaction scale, and 5-level EuroQol 5-dimensional questionnaire, which will be assessed before starting the trial and after 2 and 4 weeks. This study aims to investigate the efficacy, safety, and economic feasibility of WBGCT in the treatment of chronic cough. Therefore, the results of this trial provide evidence for the application of WBGCT in the treatment of UACS-induced chronic cough.
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subjects Antihistamines
Asthma
Blood pressure
Care and treatment
Clinical trials
Cough
Diagnosis
Double-blind studies
Economic aspects
Evaluation
Gastroesophageal reflux
Hay fever
Histamine
Medical research
Medicine, Botanic
Medicine, Experimental
Medicine, Herbal
Participation
Patient satisfaction
Respiratory diseases
Rhinitis
Safety and security measures
Sinusitis
Study Protocol
Womens health
title Efficacy, Safety and Economic Evaluation of Wolbigachul-Tang for Chronic Cough Due to Upper Airway Cough Syndrome (UACS): A Study Protocol for Randomized, Double-Blind, Active-Comparator Controlled, Parallel, Exploratory Clinical Trial
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