KCT0003126招募中未知
Clinical study to evaluate the effects and safety of Panax Ginseng Mayer extract and red ginseng to body temperature
Kyung Hee University Hospital0 个研究点目标入组 180 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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 64(Year)（—）
- 性别
- All
入选标准
- •1) Subjects who agree to participate in this study and have given their written informed consent
- •2) Men and women aged 20 to under 65, excluding an illiterate
排除标准
- •1) Present or previous significant allergy to any health supplements and medicine, including ginseng
- •2) History or presence of any clinically significant medical condition such as dementia, brain tumor, hydrocephalus.
- •3) History or presence of clinically significant medical condition such as stroke, heart disease (heart failure, angina, myocardial infarction), malignant disease, narrow angle glaucoma, resistant hypertension, lung disease.
- •4) Subjects who have clinical manifestation associated renal or hepatic disorders (serum creatinine > 2.0 mg/dL, liver function test: ALT, AST > 2.5 times of the upper limit of normal range)
- •5) Subjects who show the following results;
- •- Fasting blood glucose ? 160 mg/dL, despite of taking oral antidiabetic agents
- •- Platelet ? 150,000/mm3, WBC ? 4,000/mm3, Hemoglobin ? 9.5 g/dL for men or ? 9.0 g/dL for women
- •6) Use of the medications or products such as oral steroid, hormones within 3 months prior to the scheduled study drug administration.
- •7) Subjects who have been taking medication or functional food, known to interfere with the absorption, metabolism and elimination of study drug (test food) or Subjects who participated in any other clinical trial within 3 months prior to the scheduled study drug administration
- •8) Subjects who have undergone surgical procedures within 6 months prior to the scheduled study drug administration or who have are taking medications such as herbal supplements (ginseng) or herbal medicine within 1 months prior to the scheduled study drug administration
- •9) Any condition possibly affecting drug absorption such as gastrectomy
- •10) Pregnant women, lactating women, or unable to take effective contraceptive measures (oral contraceptive pills, birth control implants, intrauterine devices, condoms, spermicides)
- •11) Donation of a unit of blood within two months, or of blood components within one month, or receipt of blood transfusion within one month before the first administration of the study drug
- •12) Subjects who do not follow informed-consent rules, or who are judged by the investigator to be inappropriate for inclusion in the study
研究者
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