KCT0008815已完成Unknown
Randomized assignment, double-blind, parallel design, placebo-controlled human application test to evaluate the effectiveness and safety of erythema complexes on the excrement of ingested fat
B&Tech0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1) Participants who aged betwen 19-65.
- •2) Participants whose body mass index (BMI) is between 20-30 kg/m2 when measured on visit 1.
- •3) Participants who regularly defecate daily (once or twice a day).
- •4) Participants who voluntarily agreed to this clinical trial and submitted written consent before the study begins.
排除标准
- •1) Participants who are receiving treatments for severe cardiovascular, immune, respiratory, gastrointestinal, hepatobiliary (including abnormality in liver function), nephrourinary (including abnormality in renal function), nervous, psychotic, thyroidal, infectious, and malignant neoplastic diseases (but investigators can enroll depending on the participant’s condition).
- •2) Participants who had eating disorders including bulimia nervosa and anorexia nervosa within twelve months from visit 1.
- •3) Participants who had gastrointestinal operation (including obestiy operation), except for cholecystectomy and appendectomy.
- •4) Participants who have difficulty in taking the test supplement due to gastrointestinal disorder.
- •5) Participants who have irritable bowel syndrome (including diarrhea-predominant, conspitation-predominant, and mixed stool pattern)
- •* Participants who have had symptoms six months ago from diagnosed time, have abdominal discomfort or pain more than three days a month during last three months, and who corresponds to more than two items of the followings;
- •(1) Those symptoms are ameliorated by defecation.
- •(2) The number of defecation was changed accompanying with those symptoms.
- •(3) The shape and thickness was changed accompanying with those symptoms.
- •6) Participants who have histories of drug abuse and disorders due to alcohol use.
- •7) Participants who have uncontrolled hypertension (=160 mmHg of systolic blood pressure or =100 mmHg of diastolic blood pressure when measured after 10 minutes of relaxation).
- •8) Participants who have diabetes and are taking antidiabetic drugs (including oral hypoglycemic agent and insulin).
- •9) Participants who have taken drugs affecting blood lipids (including fibrates, cholestins, laxatives, phytosterol margarines, systemic corticosteroids), antiobestic drugs (including anoretic agents, fat uptake inhibitors, and GLP-1 receptor agonists), antipsychotics (including antidepressants and antischizophrenic drugs), hypolipidemic drugs (including fish oil, statins, bile acid sequestrants, and niacin), and health functional foods for lowering blood lipids and cholesterol (such as oils including EPA, DHA, gamma-linolenic acid, indigestible maltodextrin, lecithin, and phytosterols).
- •10) Pregnant, nursing women or women who planning pregnancy.
- •11) Participants who were recruited other intervened clinical trials within three months from visit 1, or who are going to participate in other intervened clinical trials after this study began.
- •12) Participants who are sensitive to the ingredients of test supplement.
- •13) Others who are determined to be unsuitable by investigators.
研究者
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