NCT01424748已完成1 期
A Single Centre, Double-blind, Three Dose Level, Parallel Group, Placebo Controlled Safety Study With Tahitian Noni Juice in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Safety
研究概览
简要总结
For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be made for each volunteer during the pre-study screen and at week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects were male or female, aged between 18 and 65 years inclusive.
- •Subjects had a BMI of between 19 and 30 kg/m2 inclusive.
- •Prior to study commencement, subjects signed and dated a witnessed informed consent form.
- •Subjects had a satisfactory documented medical history during the 21 days prior to study commencement.
- •Normal blood biochemistry, haematology, urinalysis and ECG were confirmed during the 21 days prior to study commencement.
- •Subjects had negative virology profile (hepatitis B surface-antigen and hepatitis C virus antibody) confirmed during the 21 days prior to study commencement.
- •Females of child-bearing potential had a documented negative urine pregnancy test and were not lactating or trying to become pregnant during the course of the study. They were using an adequate method of contraception. A female of non-childbearing potential was defined as one who had been post-menopausal for at least 12 months, had been surgically sterilised, or had a hysterectomy at least 3 months prior to study start.
排除标准
- •Subjects with any evidence or history of clinically significant hepatic or renal disorder, cardiovascular, respiratory, metabolic, immunological, neurological, psychiatric or gastrointestinal disease.
- •Subjects with a history of asthma or allergic skin rash or other relevant allergic reaction.
- •Subjects with known hypersensitivity or intolerance to drugs in general.
- •Subjects with a history of alcohol abuse (more than 28 units per week for males and more than 21 units for females).
- •Subjects who tested positive for hepatitis B surface-antigen and hepatitis C virus antibody.
- •Subjects who had been on a course of prescribed drug treatment within 28 days of the study start that had not been approved by the Principal Investigator.
- •Subjects who had taken any over the counter (OTC) drugs, vitamins, herbal remedies or used topically applied preparations within one week of study start unless the Principal Investigator had given approval.
- •Subjects who smoked more than five cigarettes daily.
- •Subjects who participated in a clinical trial or donated more than 500 ml of blood in the three months prior to study commencement.
- •Female subjects who were pregnant, lactating or trying to become pregnant during the course of the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo juice
干预措施: Placebo (Dietary Supplement)
30 mL Tahitian Noni Juice
Experimental
30 mL Tahitian Noni Juice per day dose
干预措施: Tahitian Noni Juice (Dietary Supplement)
300 mL Tahitian Noni Juice
Experimental
300 mL Tahitian Noni Juice per day
干预措施: Tahitian Noni Juice (Dietary Supplement)
750 mL Tahitian Noni Juice
Experimental
750 mL Tahitian Noni Juice per day
干预措施: Tahitian Noni Juice (Dietary Supplement)
结局指标
主要结局
Safety
时间窗: 6 weeks
Adverse events, electrocardiograms, vital signs, and clincial laboratory measurements recorded on day 0, 2 weeks, 4 weeks, and 6 weeks.
次要结局
未报告次要终点
研究者
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