Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol
Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen...
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Elsevier
2017-09-01
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| Series: | Integrative Medicine Research |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422016301883 |
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| author | Jihye Kim Hyunho Kim Keun Ho Kim |
| author_facet | Jihye Kim Hyunho Kim Keun Ho Kim |
| author_sort | Jihye Kim |
| collection | DOAJ |
| description | Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency.
Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print.
Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.
Trial Registration No.: KCT0002114 (date of registration: October 21, 2016). |
| format | Article |
| id | doaj-art-979d7f5f4c2549e1bc85e371be906a26 |
| institution | DOAJ |
| issn | 2213-4220 |
| language | English |
| publishDate | 2017-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj-art-979d7f5f4c2549e1bc85e371be906a262025-08-20T03:09:54ZengElsevierIntegrative Medicine Research2213-42202017-09-016331732410.1016/j.imr.2017.07.003Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocolJihye Kim0Hyunho Kim1Keun Ho Kim2KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, KoreaDepartment of Biofunctional Medicine & Diagnostics, College of Korean Medicine, Kyung Hee University, Seoul, KoreaKM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, KoreaBackground: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT. Trial Registration No.: KCT0002114 (date of registration: October 21, 2016).http://www.sciencedirect.com/science/article/pii/S2213422016301883Bu-Zhong-Yi-Qi-Tangfunctional dyspepsiaherbal medicinetraditional Korean medicine |
| spellingShingle | Jihye Kim Hyunho Kim Keun Ho Kim Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol Integrative Medicine Research Bu-Zhong-Yi-Qi-Tang functional dyspepsia herbal medicine traditional Korean medicine |
| title | Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol |
| title_full | Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol |
| title_fullStr | Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol |
| title_full_unstemmed | Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol |
| title_short | Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol |
| title_sort | effects of bu zhong yi qi tang for the treatment of functional dyspepsia a feasibility study protocol |
| topic | Bu-Zhong-Yi-Qi-Tang functional dyspepsia herbal medicine traditional Korean medicine |
| url | http://www.sciencedirect.com/science/article/pii/S2213422016301883 |
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