KCT0008678已完成Unknown
The effect of immune system enhancement through an 8-week supplementation of a complex extract of Portulaca oleracea L. and Perilla frutescens var. japonica Hara (PPCE): a randomized, double-blind, placebo-controlled crossover trial.
MnF Korea0 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
- Unknown
- 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
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •All research subjects participated in the human application test by satisfying the following criteria.
- •1) Adult men and women between the ages of 20 and 75 at the time of screening
- •2) A person who voluntarily decides to participate after listening to and fully understanding the detailed explanation of this study and agrees in writing to abide by the precautions.
排除标准
- •Research subjects were excluded from participation in the human application test if any of the following criteria were me ;
- •1) A person whose WBC is less than 3000/µl or greater than 8000/µl in the screening test.
- •2) Subjects with a BMI of less than 18.5 kg/m2 at the time of screening
- •3) Those with a history of drug and clinically significant hypersensitivity reactions
- •4) Those with thyroid or pituitary disease
- •5) Those with acute severe cardiovascular disease such as renal failure, myocardial infarction, or stroke
- •6) Those who have or have a history of immune system disease or severe liver or kidney failure
- •7) Those who have or have a history of systemic diseases such as malignant tumors, lung diseases, leukemia, collagen disease, multiple sclerosis, allergic skin diseases and other autoimmune diseases
- •8) Those diagnosed with diabetes
- •9) Those with a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of the product for human application test
- •10) A person who has experience of consuming medicines, herbal medicines, or health functional foods that can affect immunity within 2 weeks before the first intake of products for human application (in the case of health functional foods, after a one-week withdrawal period before the first intake) can participate)
- •11) Those who have received antipsychotic drug treatment within 2 months prior to screening
- •12) Those who have a history of treatment for alcoholism or drug abuse
- •13) Those who participated in other human application tests within 2 months before the screening test
- •14) A person who shows the following results in a laboratory test
- •? AST or ALT > twice the upper limit of the reference range
- •? Serum Creatinine > 2.0 mg/dl
- •15) Pregnant or lactating women
- •16) If women of childbearing potential do not accept proper contraception (except for women who have undergone sterilization)
- •17) A person who is judged unsuitable for participation in the study by the director of the study due to other reasons, including diagnostic test results.
研究者
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