KCT0004387已完成未知
A 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of ISD(Angelica gigas nakai. extract) on immune function
Medience0 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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Male or female subjects aged from 20 to 75 years old
- •2) Those that correspond to at least two of the following items
- •? Subjects who exercise more than 20 minutes a day (a severe physical activity that requires a little more
- •breathing than usual and a physical effort to increase heart rate) are within twice a week
- •? Subjects with a body mass index (BMI) of less than 18.5 kg/m2 or more than 27.5 kg/m2
- •? Triglyceride more than 150mg/dL
- •? HDL-C of less than male 40mg/dL or female 50mg/dL
- •? Subjects who have smoked more than 20 pieces a day and more than 3 years
- •? Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to
- •cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis,
- •laryngitis, sinusitis, otitis media, rhinitis, Stomatitis, etc.)
- •3) Subjects with a Perceived Stress Scale(PSS) index of 18 or above
- •4) Satisfied with 1)~3) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent
排除标准
- •1) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients
- •2) subject who have thyroid gland or pituitary gland disease
- •3) Subjects who have acute severe cerebrovascular and cardiovascular disease such as renal failure, myocardial infarction, stroke
- •4) Subjects who have immune system disease or severe liver failure, renal failure or history
- •5) Subjects who have systemic diseases such as malignant tumors, lung diseases, leukemia, collagenosis, multiple sclerosis, allergic skin diseases and other autoimmune diseases or history
- •6) Vaccinated within 3 months before screening
- •7) Subjects who have uncontrolled high blood pressure(Higher than 160/100mmHg, measured 5 minutes after stabilizing) or Glucose level is above 130
- •8) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
- •9) Subject who have experienced taking medicines, herbal medicines, and health functional foods that may affect their immune system within two weeks prior to the first intake of the test product (the health functional foods can be participated after a week's recess before the first intake of the clinical product)
- •10) Subject who get a medical history of psychopharmacotherapy with in last 2 months before screening test
- •11) Subjects who are suspected drug abuse or have a medical history of dependent on drug
- •12) Participation in other clinical trials within the previous three months
- •13) Subject who show the following results in the screening test
- •? AST, ALT > more than 2 times of the upper limit
- •? Serum creatinine > 2.0 mg/dL
- •14) Subjects who are pregnant and breastfeeding female
- •15) Subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation)
- •16) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
研究者
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