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Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial

Gajin Han1, Jae-Woo Park2, Seok-Jae Ko1, Jihee Son2, Jongki Seon1, Juyeon Kim1, Seulki Kim1, Inkwon Yeo3, Bongha Ryu2 and Jinsung Kim2*

Author Affiliations

1 Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea

2 Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea

3 Department of Statistics, Sookmyung Women’s University, Seoul, Republic of Korea

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Trials 2013, 14:281  doi:10.1186/1745-6215-14-281

Published: 3 September 2013

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

Keywords:
Xerostomia; Yukmijihwang-tang; Yin-Deficiency; Visual analogue scale