KCT0005265已完成未知
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 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •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? ?? ?
- •11) AST(GOT) ?? ALT(GPT)? ???? ?? ???? 3? ??? ?
- •12) TSH? 0.1 µIU/ml ????? 10 µIU/ml ??? ?
- •13) ? ??????? ??? ????? ????? ?? ?
- •14) ?? ???? ?? ? ?? 3?? ??? ??? ???? ?? ?
- •15) 1?? ??? ?? ??????? ??????, ? ?????? ?? ?? ?? ??????? ??? ??? ?? ?
- •16) ???? ? ??????? ?????? ???? ?
- •17) ??? ???(????) ? ????????? ????? ???
排除标准
- •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
- •11) Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution
- •12) TSH of 0.1 µIU/ml or less or 10 µIU/ml or more
- •13) Persons who are sensitive or allergic to investigational product for this clinical trial
- •14) Pregnant, lactating or planning to become pregnant within 3 months
- •15) Those who participated in other clinical trials within 3 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trials.
- •16) A person who determines that the Investigator is inappropriate for clinical trials
- •17) Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital
研究者
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