KCT0003608已完成未知
Multi-center single sided preliminary study to evaluate effectiveness and safety in administrating CNU capsule to refractory functional dyspepsia patients
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 37 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
This clinical trial was conducted to find out whether reciprocal symptoms and stability after taking CNU capsules in patients with refractory functional dyspepsia. In conclusion, it was confirmed that taking CNU capsules in patients with refractory functional dyspepsia significantly improved symptoms without any noticeable side effects.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1. Person over 19 years old as of the date of submission
- •2. Among patients with FD diagnosed by the Rome IV criteria, patients with RFD
- •- Person who have had early satiation and bothersome postprandial fullness for minimum 3 days a week and epigastric pain and epigastric soreness for minimum 1 day a week
- •- Person with above symptoms that started at least 6 months before and continused for minimum 3 months
- •- Person having no possible causes of above symptoms including organic disease, structural modification, systemic disease, and endocrinology-metabolic disease
- •- Person who do not respond to at least 2 general treatments for FD
- •- Dyspepsia symptoms that can disrupt daily life (global overall symptom scale score =>5)
- •3. Persons who submitted written consent to participate in this study
排除标准
- •1. Patient with biliary disease other than bile stone, scraps in the gall and bile tract, and polyps of gallbladder
- •2. Patient with structurally abnormal biliary system from congenital malformation or other reasons
- •3. Patients with endocrinology-metabolic disease that can affect mobility of gastrointestinal tract and biliary system such as diabetes and abnormal thyroid function
- •4. Patient who cannot discontinue any drug that can provoke abdominal symptoms
- •5. Patient with disease or damage in central nervous system (cerebral hemorrhage and cerebral infarction with residual disorder) and autonomic nervous system (vertebrate)
- •6. Patient with renal disorder and electrolyte imbalance
- •7. Patient who received gastrointestinal surgery (excluding appendectomy and hemorrhoidectomy)
- •8. Patient with frequent biliary colic or infection of biliary infection
- •9. Obstructive jaundice patient
- •10. Severe renal disease patient
- •11. Patient with variceal bleeding, hepatic coma, ascites, and needs for acute liver transplantation
- •12. Patient with severe pancreatic disease
- •13. Person scheduled to receive combined administration of below drugs:
- •- Drug with considerable hepatic toxicity
- •Antacid agent containing cholestyramine, medical charcoal, magnesium and aluminum hydroxide
- •- alpha-methydopa
- •- Drug to increase bile secretion of cholesterol ( estrogen, hormonal contraception agent, partial lipid lowering agent), drug
- •to reduce blood cholesterol
- •14. Patient with hypersensitivity to this drug or any component of this drug
- •15. Patient with severe biliary obstruction
- •16. Patient with radiopaque, calcificated bile stone
- •17. Patient with acute cholecystitis
- •18. Patient with peptic ulcer
- •19. Patient with coloenteritis like Crohn disease
- •20. Cholestasis patient
- •21. Patient with abnormality in gallbladder contraction (below 40% of GB ejection fraction)
- •22. Person relevant to below criteria, as results of tests conducted in screening
- •- Person with BUN exceeding 3 times of normal upper limit
- •- Person with blood creatinine exceeding 3 times of normal upper limit
- •- Person with total bilirubin exceeding 3 times of normal upper limit
- •- Person with direct bilirubin exceeding 3 times of normal upper limit
- •- Person with AST(sGOT) and ALT(sGPT) exceeding 3 times of normal upper limit
- •- Person with ALP(alkaline phosphatase) exceeding 3 times of normal upper limit
- •- Person with GGT(gamma-glutamyl transferase) exceeding 3 times of normal upper limit
- •23. Woman who is pregnant or lactating and women in childbearing age who uses no reliable contraceptive measure or doesn’t agree to keep contraception during pregnancy period
- •24. Person who cannot understand purpose and methods of this study such as mental patients or patients with drug and alcohol abuse
- •25. Other persons considered by any investigator to have some difficulties in performing this study
研究者
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