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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10606134/ https://www.ncbi.nlm.nih.gov/pubmed/37893807 http://dx.doi.org/10.3390/healthcare11202733 |
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author | Woo, Seong-Cheon Lyu, Yee Ran Lee, Su Won Kwon, O-Jin Choi, Young-Eun Yang, Changsop Park, Yang Chun |
author_facet | Woo, Seong-Cheon Lyu, Yee Ran Lee, Su Won Kwon, O-Jin Choi, Young-Eun Yang, Changsop Park, Yang Chun |
author_sort | Woo, Seong-Cheon |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-10606134 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-106061342023-10-28 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 Woo, Seong-Cheon Lyu, Yee Ran Lee, Su Won Kwon, O-Jin Choi, Young-Eun Yang, Changsop Park, Yang Chun Healthcare (Basel) Study Protocol 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. MDPI 2023-10-13 /pmc/articles/PMC10606134/ /pubmed/37893807 http://dx.doi.org/10.3390/healthcare11202733 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Study Protocol Woo, Seong-Cheon Lyu, Yee Ran Lee, Su Won Kwon, O-Jin Choi, Young-Eun Yang, Changsop Park, Yang Chun 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10606134/ https://www.ncbi.nlm.nih.gov/pubmed/37893807 http://dx.doi.org/10.3390/healthcare11202733 |
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