KCT0005265
Completed
未知
A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the evaluation of the efficacy and safety of RW0117 on dyspepsia
Richwood Trading Company, LTD.0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Richwood Trading Company, LTD.
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) ?? 6?? ??? ??? ????, ??? ??(???, ??? ?), ?? ??(???, ????, ???, ??? ??? ?? ???) ?? ??? ?? ? (?, ????? ??? ?????? ???? ??? ??? ??? ?? ??? ??? ? ??.)
- •2\) 6?? ??? ??? ?? ? ??? ??? ?? ??? ?? ?
- •3\) ??? ???? ?? ?(??????? ? ????? ??)
- •4\) ???? ????? ??? ?? ??
- •5\) ??1 ?? 2? ??? H2 ??? ???, ????(???? ??? ???), ???? ??? ???, ??????? ??, ??? ?? ???, ??????, ?? ?? ?? ??? ??, ? ?? ??????? ??? ?
- •6\) ?????? ?? ?? ????????, ??????? ???, ???? ? ??? ???? ? ?? ??? ????? ???? ?? ?
- •7\) ?? ?? ???? ?? 1?? ?? 1??? ?? ?? 14unit, ?? 7unit ??? ??? ?? ??? ?? ?
- •8\) ???? ?? ??? ??(??? ?? 160mmHg ?? ?? ??? ?? 100mmHg ??, ?????? ??? 10? ?? ? ????)
- •9\) ??? ???? ?? ??? ?? (?? ??? 180mg/dl ??)
- •10\) Creatinine? ???? ?? ???? 2? ?? ?
Exclusion Criteria
- •1\) Patients with a history of severe malignant tumors, cerebrovascular disease (cerebroinfarction, brain hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the past 6 months (but clinically In the case of a stable human\-applied test subject, the tester can participate in the test.)
- •2\) Persons with a history of peptic ulcer and reflux esophagitis within 6 months
- •3\) Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)
- •4\) Patients with a history of malignancy of the digestive system
- •5\) Those who have taken H2 receptor blockers, anticholinergic drugs (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health functional food within 2 weeks of Visit 1
- •6\) Those who need to continuously take drugs that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti\-inflammatory drugs, aspirin, etc.
- •7\) In the drinking habit questionnaire, those who had an average alcohol consumption habit of 14 units or more for men and 7 units per week for the past month.
- •8\) Uncontrolled hypertension patients (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement standard after 10 minutes of human body test)
- •9\) Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg/dL)
- •e is more than twice the normal upper limit of the test institution
Outcomes
Primary Outcomes
Not specified
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