Availability of Tongue Diagnosis System for Assessing Tongue Coating Thickness of Patients With Functional Dyspepsia: Study Protocol for Comparative Trial With Conventional Method
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- tongue coating thickness(TCT) by tongue diagnosis system
研究概览
简要总结
The aim of the proposed study is to investigate the agreement between the measurement of the tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).
详细描述
Tongue diagnosis is one of the important diagnostic techniques to examine the physiologic functions and pathologic changes of the internal organs in TKM.
However, traditional tongue diagnosis has inevitable limitations because of the clinician's subjectivity and environmental factors influencing on the diagnostic results.
Therefore, it is necessary to investigate the availability of the tongue diagnosis system (TDS).
The aim of the this study is to investigate the agreement between the measurement of TDS and the conventional way of tongue diagnosis about TCT in the tongue diagnosis of TKM. So, we will assess the agreement between the measurement of TDS and the final diagnosis of 5 clinicians with five or more years of clinical experience about TCT.
Additionally, we will evaluate the reproducibility of TDS. In the 2nd visit, taking tongue images of each patient with TDS will be performed again at 30 minute-intervals in the same way. And then, we will compare the two TDS measurements of each patient about TCT.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older
- •One who meet the Rome III criteria for functional dyspepsia
- •One who is able to read, write, hear, see something
- •One who agree on consent form
排除标准
- •Mental disorders
- •Pregnancy
- •Severe systemic organ diseases such as cancer
- •Infectious or other serious consumptive diseases
- •Geographic tongue
- •One who cannot open his/her mouth or protrude his/her tongue
结局指标
主要结局
tongue coating thickness(TCT) by tongue diagnosis system
时间窗: 2nd visit (1st visit is for screening)
In the 2nd visit, Tongue coating thickness(TCT) will be assessed by tongue coating percentage(%)from TDS measurements. In the advanced study, 29.06% is a cut-off point to separate no coating and thin coating, and 63.51% is a cut-off point to separate thin coating and thick coating.
次要结局
- tongue coating thickness(TCT) by the five clinicians(After completing the collection of 60 patients' tongue images)
- the weight of tongue coating(2nd visit (1st visit is for screening))
研究者
Jin-sung Kim
Full professor
Korea Health Industry Development Institute