KCT0004085
Completed
未知
A single-center, randomized, double-blind, Placebo-controlled, Intervention study for the efficacy and safety of BST104 in mild to moderate functional dyspepsia subjects
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 92
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult male and female over 19 years old
- •Patients diagnosed with functional dyspepsia (Rome3 criteria) who did not require immediate medication due to upper abdominal discomfort or persistent / recurrent pain
- •Those who agree to the written consent of the applicant and who can cooperate with the necessary visits and related tests and surveys for the study process
Exclusion Criteria
- •1\. Subjects who are allergic to natural products and drug ingredients
- •2\. Endoscopic examination of stomach: LA\-A reflux esophagitis, gastric ulcer diagnosis, acute gastritis requiring treatment
- •3\. Subjects who have had past gastric acid suppression surgery or stomach and esophagus surgery, except for closure of the ulcer or oversewing surgery
- •4\. Subjects who need to take a steroids, bestero\-inflammatory drugs, aspirin, or other drugs that can cause ulcers every day (but low\-dose aspirin for cardiovascular disease)
- •5\. Subjects diagnosed with malignant tumors within 5 years
- •6\. Subjects who drink more than 4 times a week
- •7\. Severe liver dysfunction (\> 2\.5 times normal upper limit of ALT, AST, r\-GT) or serious liver dysfunction
- •8\. Chronic kidney disease or severe renal disease including kidney dysfunction
- •9\. Unregulated diabetes, cerebrovascular disease and Subject has been diagnosed within 3 months of the disease requiring surgery
- •10\. Diagnosed within 3 months of the following diseases (Zollinger\-Ellison syndrome, primary esophageal motility disorder, esophageal stricture, malignant disease of the gingival ulcer or upper gastrointestinal tract, pancreatitis, absorption disorder, severe cardiovascular disease or pulmonary disease)
Outcomes
Primary Outcomes
Not specified
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