KCT0001920招募中未知
Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System: a randomized, double-blinded, placebo-controlled, multi-center clinical trial
Dong-Eui University Oriental Medicine Hospital0 个研究点目标入组 96 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. Individuals between the ages of 19 and 75 years
- •2. Individuals who meet the Rome III functional dyspepsia criteria
- •3. Individuals who check more than 40 points on the visual analogue scale (0-100) for dyspeptic symptoms
- •4. Individuals who voluntarily agree with a study protocol and sign a written informed consent
排除标准
- •1. Individuals who have peptic ulcer or gastroesophageal reflux disease
- •2. Individuals who have obvious signs of irritable bowel syndrome
- •3. Individuals who have alarm symptoms (weight loss, black or tar stool, or dysphagia)
- •4. Individuals who have serious structural disease (malignant tumors, disease of heart, lung, liver or kidney) or mental illness
- •5. Individuals who have had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago
- •6. Individuals who have other structural disease related with the gastrointestinal tract (e.g., cholangitis, pancreatitis)
- •7. Individuals who have had maxillofacial surgery or facial bone contouring surgery
- •8. Individuals who are taking drugs which might affect the gastrointestinal tract (Proton-pump inhibitors(PPIs), H2 antagonists, Antacids, gastrointestinal motility promoters, antibiotics, Nonsteroidal anti-inflammatory drugs(NSAIDs), muscle relaxants, antidepressants, stabilizer); a minimum wash-out period of one week is required before participating in the trial
- •9. Individuals who are pregnant or breastfeeding
- •10. Individuals who have a problem of malabsorption or maldigestion
- •11. Individuals who are human immunodeficiency virus(HIV) positive
- •12. Individuals who have difficulty in attending the trial (e.g., severe mental or psychological abnormality, dementia, drug addiction, time constraint, severe disorder in vision or hearing, outpatient treatment impossibility, illiteracy)
- •13. Individuals who have taken any other Investigational drug within 3 months
研究者
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