JPRN-jRCT1070220018进行中（未招募）2 期
Efficacy and Safety of Hot Spring Water 99 of Blood Glucose and Intestinal Variability: An Open Randomized Placebo-Controlled Two-sequence Two-Phase Crossover Phase IIb Study
Ohishi Mitsuru0 个研究点目标入组 20 人开始时间: 2022年6月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients providing written informed and consent to participate in the study.
- •2) Aged >= 20 years (irrespective of sex).
- •3) Patients with HbA1c levels in the boundary range(5.6-6.4%).
排除标准
- •1) Patients who have taken, or plan to take during this study, medications that may affect this study (antiallergic drugs, bowel preparations, laxatives, etc.) since the pre- test.
- •2) Patients who regularly use medicines for diabetes.
- •3) Patients who have taken antibiotics before one month prior to the start of drinking water for study, or plan to do so during this study period.
- •4) Patients who have been using food for specified health uses, functional foods, supplements, or health foods that may affect this study for more than 3 days a week prior to participation in this study.
- •5) Patients with a history of appendicectomy.
- •6) Patients who have undergone surgery that may affect the test within six months prior to the date of the pre-test (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, etc.)
- •7) Heavy drinkers of alcohol.
- •8) Patients with extremely irregular dietary habits or irregular rhythms of life (shift workers, late-night workers, etc.)
- •9) Patients who are during participating in a clinical trial of another drug or health food, or who plan to participate in another clinical trial within 4 weeks after the completion of this trial or after consenting to participate in this trial.
- •10) Pregnant women, those who plan or may become pregnant, and those who are breastfeeding.
- •11) Patients with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc.
- •12) Patients with allergies to medicines or food.
- •13) Patients who have donated component blood or 200mL whole blood for the month prior to the screening test.
- •14) Men who donated 400 mL of whole blood for 3 months prior to the screening test.
- •15) Women who donated 400 mL of whole blood for 4 months prior to the screening test.
- •16) Men whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 1200 mL.
- •17) Women whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 800 mL.
- •18) Employees of SOC Corporation and their families.
- •19) Patinets who are judged inappropriate to participate in this study by the principal investigator or sub-investigator.
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