KCT0006657已完成未知
A 8-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Beta-Glucan derived from Split gill Mushroom, Schizophyllum commune Fr. for improving intestinal health
Quegen Biotech0 个研究点目标入组 80 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
- 80
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) Male or female subjects aged from 19 to 70 years old.
- •2) Subjects who meet the diagnostic criteria for functional constipation in Roman Standard IV
- •This applies to two or more of the following six items.
- •(However, there is no watery stool or watery diarrhea for the last 3 months, and it should not meet the criteria for diagnosing irritable bowel syndrome)
- •? If there have been bowel movements less than 3 times a week in the last 3 months.
- •? If there has been more than 1 out of 4 solidified and lumped bowel movements in the last 3 months.
- •? If there have been given excessive force to stool in the last 3 months more than 1 out of 4 bowels movements.
- •? If there has been the feeling of leftover stool after bowel movements in the last 3 months more than 1 out of 4 bowel movements.
- •? If there has been feeling that the bowel movement has not come out (stool is clogged) during the last 3 months.
- •? If there has been experience of pressing around the anus or removing the stool with your hand in order to completely see the bowel movement more than 1 out of 4 bowel movements.
- •3) Subjects who voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this human application test.
排除标准
- •1) Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs and human testing products
- •2) Subjects with clinically significant digestive system, rectal anal disease, liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, mental disease, cardiovascular disease, etc.
- •3) Subjects who meet the criteria for diagnosing irritable bowel syndrome in Roman criteria IV.
- •This applies to two or more of the following three items.
- •(However, there has to be abdominal pain at least once a week on average in the last 3 months.)
- •? If abdominal pain is related to bowel movements
- •? If abdominal pain is accompanied by a change in the number of bowel movements
- •? If abdominal pain is accompanied by a change in stool shape
- •4) Subjects with a history of gastrointestinal diseases (eg, Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of the test product for human application
- •5) Subjects who took specialty drugs related to intestinal health within one month from the date of screening test (see Concomitant Drugs)
- •6) Subjects who have taken herbal medicines or health functional foods related to intestinal health within 2 weeks from the date of screening test
- •7) Subjects who have received anti-psychotic drug treatment within 2 months from the date of screening test
- •8) Subjects who participated in other interventional human application tests within 3 months from the date of screening test
- •9) Subjects who have a history of alcoholism or substance abuse or suspected
- •10) Subjects who show the following results in the diagnostic laboratory medical examination (AST, ALT> 3 times the upper limit of the normal range, serum creatinine> 2.0 mg/dL)
- •11) Pregnant or lactating women
- •12) Women of childbearing potential who are likely to become pregnant and do not accept the implementation of appropriate contraceptive methods (expect for women who have undergone sterilization)
- •13) Subjects who are judged to be unsuitable for participation in the research due to the results of diagnostic laboratory medical examination and other reasons
研究者
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