None listed
Conditions
Interventions
Drug : All subjects take 250mg CNU capsule orally 1 capsule per time, 2 times a day (morning, evening / at meal or after meal) for 12 weeks.
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-point Global Overall Symptom Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring of clinical abnormal response;Vital signs;Clinical laboratory test | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Ill Jang
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed