KCT0008045已完成未知
A 12 week, Randomized, Double-Blind, Placebo-Controlled, Exploratory Clinical Trial for the Evaluation of the Efficacy and Safety of BA on Inflammatory Bowel Disease(Ulcerative Colitis)
Hongcheon Institute of Medicinal Herb0 个研究点目标入组 30 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
- 30
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) adults over 19 and under 70
- •2) Mayo Clinic Score (MCS) with a total score of 3 or more and 10 or less
- •3) A person who is able to maintain IBD treatment drugs (such as 5-ASA) in accordance with IBD treatment standards and prescriptions by the person in charge of treatment
- •4) A person who agrees to participate in the human body application test and signs a written consent form prior to the commencement of the human body application test
排除标准
- •1) A person who is currently being treated for infectious diseases including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, mental health, and skin
- •2) A person with a history of forearm resection
- •3) Those who are likely to undergo bowel resection within 3 months
- •4) A person who has a history of solid cancer and blood cancer within five years;
- •5) People with autoimmune diseases including Crohn's disease
- •6) A person who has or has complications such as stenosis or perforation in the gastrointestinal tract
- •7) A person who has administered immunomodulators or biological agents such as systemic steroids, TNF-a Inhibitors, Azathioprine, and MTX within 3 months of visit 1
- •8) Those who consume excess alcohol within one year (men > 210 g/week, women > 140 g/week) based on visit 1
- •9) BMI = 30 kg/m2 factor
- •10) Patients with uncontrolled hypertension (measured after stabilizing for 10 minutes with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher)
- •11) Uncontrolled diabetics (above 180 mg/dL of fasting blood sugar)
- •12) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution;
- •13) A person whose creatinine is twice or more than the upper limit of the implementation agency's normal limit
- •14) A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
- •15) A person who has participated in other interventional clinical trials (including human application tests) within 3 months of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
- •16) A person who is sensitive to or allergic to food ingredients for this human body application test
- •17) A person who judges that the tester is inappropriate for other reasons
研究者
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