Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized,Double-blind, Placebo-controlled, Two-center Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS) for xerostomia
研究概览
简要总结
The aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.
详细描述
Xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.It can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia.
The purpose of the current trial is to investigate the effect of herbal extract granule named Yukmijihwang-tang (YMT) on dry mouth. The trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. Ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of YMT or placebo. The assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks.
The primary outcomes are Visual analogue scale (VAS) for xerostomia.
The present study is designed to examine the safety and efficacy of YMT on xerostomia. Our study provides the clinical evidence of a new therapeutic strategy for xerostomia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 60 - 80
- •The visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment
- •One who has less than 0.3 ml/min of unstimulated salivary flow rate
- •One who has complained of xerostomia for at least 3months
- •One who is able to read, write, hear, see something
- •One who agree on not taking other therapies during experimental period
- •One who agree on consent form
排除标准
- •One who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc
- •One who has the history of taking radiotherapy on head and neck or history of organ transplantation
- •One who has severe mental illness such as depression
- •One who takes oriental medicine or health functional food within 2 wks before enrollment
- •One who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.
研究组 & 干预措施
Yukmijihwang-tang
Yukmijihwang-tang: Real herbal extract granule
干预措施: Herbal extract granule (Dietary Supplement)
Yukmijihwang-tang_Placebo
Yukmijihwang-tang_Placebo: Placebo herbal extract granule
干预措施: Placebo herbal extract granule (Dietary Supplement)
结局指标
主要结局
Visual Analogue Scale (VAS) for xerostomia
时间窗: Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week)
A 100 mm measurement instrument will be given to the patient and he will be instructed to indicate his severity of xerostomia in relation to the 2 extremes (0: no fatigue, 100: very severe fatigue).
次要结局
- Unstimulated Salivary Flow Rate (USFR) and Stimulated salivary flow rate (SSFR)(Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week))
- Residual saliva(Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week))
- Salivary IgA, Chromogranin A, Cortisol(Visit 1(0week), Visit 3(8week))
- Dry Mouth Symptom Questionnaire(DMSQ)(Visit 1(0week), Visit 2(4week), Visit 3(8week), Visit 4(10week))
研究者
Jin-sung Kim
Full professor
Korea Health Industry Development Institute