KCT0009505招募中未知
A 8 week, Single-center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SPB-201on gastric functional
Sungkyunbiotech0 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
- 招募中
- 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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) A person who is 19 years of age or older and 70 years of age or younger
- •2) A person diagnosed with functional dyspepsia
- •3) Those who have at least 4 of the 10 symptoms in the GIS questionnaire and have a total score of 12 or more
- •4) Where it is possible to bring the result of gastroscopy performed within 6 months, and the result sheet determines that there is no organic disease
- •5) A person who agrees to participate in this human body application test before the human body application test begins and prepares a written consent form.
排除标准
- •1)Severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, mental, infectious disease, and malignant tumor can participate in the test at the discretion of the tester.
- •2)A person who has a history of peptic ulcer or other diseases (such as colostrum disease) that may cause gastrointestinal symptoms within 6 months of visiting 1
- •3)Those with gastrointestinal surgical history (excluding appendectomy and hemorrhoids)
- •4)A person with a history of digestive malignancies
- •5)Those who have taken H2 receptor blockers, anticholinergics (muscarin receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, gastrointestinal motility boosters, and other health-related functional foods within 2 weeks of visit 1
- •6)A person who has taken drugs that can cause gastritis, such as adrenocorticotropic hormone drugs, nonsteroidal anti-inflammatory drugs, aspirin, erythromycin, and antidepressants, within 2 weeks of visiting 1
- •7)A person with a history of drug addiction
- •8) Those with alcohol consumption habits exceeding the average 30g/day for men (about 3 beers and 3 soju) and 20g/day for women (about 2 beers and 2 soju) per week in the drinking habit survey over the past month
- •9)Patients with uncontrolled hypertension (systolic blood pressure of 160mmHg or diastolic blood pressure of 100mmHg or more, test subjects after 10 minutes of rest)
- •10)Patients with uncontrolled diabetes (abdominal blood sugar greater than 180 mg/dL)
- •11)A person whose creatine is more than twice the upper limit of the normal administrative agency
- •12)Those whose AST (GOT) or ALT (GPT) is at least three times the upper limit of the normal authority
- •13)Those whose amylase and lipase are more than twice the upper limit of normal levels of the agency (but abnormal values can be excluded at the discretion of the researcher)
- •14)Those whose TSH is 0.1 µIU/mL or less, or 10 µIU/mL or more
- •15)Those who are sensitive to or allergic to food ingredients for human application tests
- •16)Pregnant or nursing mothers or those who plan to become pregnant during the period of this human body application test
- •17)A person who has participated in other interventional clinical trials (including human application tests) within three months of visiting 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
- •18)A person deemed by a tester to be inappropriate for this human body application test
研究者
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