evaluate effectiveness and safety in administrating CNU capsule to refractory functional dyspepsia patients
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003608
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-point Global Overall Symptom Scale
- Secondary Outcome Measures
Name Time Method Monitoring of clinical abnormal response;Vital signs;Clinical laboratory test