Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial
DC Field | Value | Language |
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dc.contributor.author | Han, Gajin | - |
dc.contributor.author | Park, Jae-Woo | - |
dc.contributor.author | Ko, Seok-Jae | - |
dc.contributor.author | Son, Jihee | - |
dc.contributor.author | Seon, Jongki | - |
dc.contributor.author | Kim, Juyeon | - |
dc.contributor.author | Kim, Seulki | - |
dc.contributor.author | Yeo, Inkwon | - |
dc.contributor.author | Ryu, Bongha | - |
dc.contributor.author | Kim, Jinsung | - |
dc.date.available | 2021-02-22T12:03:43Z | - |
dc.date.issued | 2013-09-03 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://scholarworks.sookmyung.ac.kr/handle/2020.sw.sookmyung/11223 | - |
dc.description.abstract | Background: Xerostomia, a subjective sense of dry mouth, is not generally regarded a disease despite its high prevalence among the elderly, and therefore continues to impair affected patients' quality of life. In traditional Korean medicine, 'Yin-Deficiency' has been implicated in the pathogenesis of xerostomia among the elderly. Yukmijihwang-tang is a famous herbal prescription used to relieve 'Yin-Deficiency', and reportedly has antioxidant effects; therefore, it is postulated that Yukmijihwang-tang can be used to treat xerostomia in the elderly. However, to our knowledge, no clinical trial has been conducted on the effects of Yukmijihwang-tang on xerostomia. Thus, we designed a randomized clinical trial to investigate the effects and safety of Yukmijihwang-tang on xerostomia in the elderly. In addition, we will clarify the aforementioned assumption that 'Yin-Deficiency' is the major cause of xerostomia in the elderly by identifying a correlation between xerostomia and 'Yin-Deficiency'. Methods/Design: This randomized, double-blind, placebo-controlled trial will be carried out at two centers: Kyung Hee University Korean Medicine Hospital and Kyung Hee University Hospital at Gangdong. We will recruit 96 subjects aged 60-80 years who have experienced xerostomia for 3 months prior to participation. Subjects who present with score >40 on the visual analogue scale for xerostomia and unstimulated salivary flow rate under 0.3mL/min will be included and the randomization will be carried out by an independent statistician by using a random number creation program. The subjects and all researchers except the statistician will be blinded to the group assignment. Yukmijihwang-tang or placebo will be administered to each group for 8 weeks. The primary outcome is change in the scores for the visual analogue scale for xerostomia and the dry mouth symptom questionnaire from 0 to 8 weeks. Discussion: It will be assessed whether Yukmijihwang-tang can be used as a new herbal treatment for xerostomia in the elderly by demonstrating its therapeutic effects in a well-designed clinical trial. Trial registration: ClinicalTrials.gov Identifier: NCT01579877 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | BMC | - |
dc.title | Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial | - |
dc.type | Article | - |
dc.publisher.location | 영국 | - |
dc.identifier.doi | 10.1186/1745-6215-14-281 | - |
dc.identifier.scopusid | 2-s2.0-84883266887 | - |
dc.identifier.wosid | 000324025100001 | - |
dc.identifier.bibliographicCitation | TRIALS, v.14 | - |
dc.citation.title | TRIALS | - |
dc.citation.volume | 14 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.subject.keywordPlus | CORTISOL | - |
dc.subject.keywordPlus | ACUPUNCTURE | - |
dc.subject.keywordPlus | DEFICIENCY | - |
dc.subject.keywordPlus | ADULTS | - |
dc.subject.keywordPlus | SALIVA | - |
dc.subject.keywordPlus | MOUTH | - |
dc.subject.keywordAuthor | Xerostomia | - |
dc.subject.keywordAuthor | Yukmijihwang-tang | - |
dc.subject.keywordAuthor | Yin-Deficiency | - |
dc.subject.keywordAuthor | Visual analogue scale | - |
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