KCT0004085已完成未知
A single-center, randomized, double-blind, Placebo-controlled, Intervention study for the efficacy and safety of BST104 in mild to moderate functional dyspepsia subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 92
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
- •11. Endoscopy within 2 weeks or before the first visit, subjects take gastrointestinal drugs such as PPI, H2 receptor antagonist, GERD treatment, or prokinetics
- •12. subjects continue to take the following drugs (diazepam, hydantoin derivative, warfarin, anticholinergic, prostaglandin analog, antineoplastic agent and more than 165 mg of salicylate, steroid, NSAISs, osteoporosis treatment)
- •13. Pregnant or nursing women
- •14. Subjects have participated in other clinical test within 4 weeks
- •15. Subjects who are judged to be unable to comply with the requirements of the test
研究者
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