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Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial

PURPOSE: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in co...

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Autores principales: Jo, Hyo-Rim, Kim, Yong-Gyun, Sung, Won-Suk, Park, Kyoung Sun, Lee, Yoon Jae, Cho, Sun Young, Seo, Byung-Kwan, Kwon, Young-Ee, Kim, Eun-Jung
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10237193/
https://www.ncbi.nlm.nih.gov/pubmed/37273271
http://dx.doi.org/10.2147/JPR.S400682
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author Jo, Hyo-Rim
Kim, Yong-Gyun
Sung, Won-Suk
Park, Kyoung Sun
Lee, Yoon Jae
Cho, Sun Young
Seo, Byung-Kwan
Kwon, Young-Ee
Kim, Eun-Jung
author_facet Jo, Hyo-Rim
Kim, Yong-Gyun
Sung, Won-Suk
Park, Kyoung Sun
Lee, Yoon Jae
Cho, Sun Young
Seo, Byung-Kwan
Kwon, Young-Ee
Kim, Eun-Jung
author_sort Jo, Hyo-Rim
collection PubMed
description PURPOSE: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in combination with standard treatment and estimate an effective dose for treating PHN. PATIENTS AND METHODS: This is a protocol for a randomized, placebo-controlled, double-blind, multicenter trial. A total of 90 eligible participants with PHN will be recruited from three hospitals and randomly allocated to high-dose group, low-dose group, or placebo group in a 1:1:1 ratio. The trial will involve a 6-week oral administration of SIKD1977/placebo, and a 1-week follow-up period. The primary outcome will be the weekly average change in average daily pain score (ADPS) from baseline to the end of treatment. The secondary outcomes will include the weekly average changes in ADPS from baseline to week 2, 4, and 7, differences in Short-Form McGill Pain Questionnaire, Visual analogue scale, 5-level EuroQol-5 dimensions, Patient Global Impression of Change, and consumption of rescue drugs. All adverse events will be assessed during the trial. CONCLUSION: This study will provide evidence for the efficacy and safety of SIKD1977, and an effective dose for PHN. TRIAL REGISTRATION: This protocol has been registered in the Clinical Research Information Service with the identification code KCT0007939.
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spelling pubmed-102371932023-06-03 Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial Jo, Hyo-Rim Kim, Yong-Gyun Sung, Won-Suk Park, Kyoung Sun Lee, Yoon Jae Cho, Sun Young Seo, Byung-Kwan Kwon, Young-Ee Kim, Eun-Jung J Pain Res Study Protocol PURPOSE: Postherpetic neuralgia (PHN) is the most common chronic complication of herpes zoster, associated with poor quality of life and increased patient and healthcare resource expenditure. This randomized controlled trial aims to evaluate the efficacy and safety of SIKD1977 (Sogeonjungtang) in combination with standard treatment and estimate an effective dose for treating PHN. PATIENTS AND METHODS: This is a protocol for a randomized, placebo-controlled, double-blind, multicenter trial. A total of 90 eligible participants with PHN will be recruited from three hospitals and randomly allocated to high-dose group, low-dose group, or placebo group in a 1:1:1 ratio. The trial will involve a 6-week oral administration of SIKD1977/placebo, and a 1-week follow-up period. The primary outcome will be the weekly average change in average daily pain score (ADPS) from baseline to the end of treatment. The secondary outcomes will include the weekly average changes in ADPS from baseline to week 2, 4, and 7, differences in Short-Form McGill Pain Questionnaire, Visual analogue scale, 5-level EuroQol-5 dimensions, Patient Global Impression of Change, and consumption of rescue drugs. All adverse events will be assessed during the trial. CONCLUSION: This study will provide evidence for the efficacy and safety of SIKD1977, and an effective dose for PHN. TRIAL REGISTRATION: This protocol has been registered in the Clinical Research Information Service with the identification code KCT0007939. Dove 2023-05-29 /pmc/articles/PMC10237193/ /pubmed/37273271 http://dx.doi.org/10.2147/JPR.S400682 Text en © 2023 Jo et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Study Protocol
Jo, Hyo-Rim
Kim, Yong-Gyun
Sung, Won-Suk
Park, Kyoung Sun
Lee, Yoon Jae
Cho, Sun Young
Seo, Byung-Kwan
Kwon, Young-Ee
Kim, Eun-Jung
Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title_full Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title_fullStr Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title_full_unstemmed Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title_short Efficacy and Safety of SIKD1977 in Combination with Standard Treatment for Postherpetic Neuralgia: Study Protocol for a Double Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Clinical Trial
title_sort efficacy and safety of sikd1977 in combination with standard treatment for postherpetic neuralgia: study protocol for a double blind, placebo-controlled, randomized, multicenter, phase 2 clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10237193/
https://www.ncbi.nlm.nih.gov/pubmed/37273271
http://dx.doi.org/10.2147/JPR.S400682
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