NCT01006460已完成不适用
A Randomized, Placebo Controlled, Parallel, Double Blinded Trial With Rhodiola Rosea Extract SHR-5 (Arctic Root) Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed
Frederiksberg University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention
研究概览
简要总结
This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home.
排除标准
- •suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease.
- •with a psychiatric diagnose, using narcotics or suffering from HIV.
- •with known allergy to any of the study medications.
- •misusing euphorizing or pain killing drugs
- •having used any adaptogenic product the last 2 months.
- •having used cortisol or any other corticosteroid products the last 6 months
- •being pregnant or breast-feeding
- •which at the first interview are judged to be not cooperative or not to be able to finalize the study
研究组 & 干预措施
Adapt 232
Experimental
干预措施: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis (Drug)
Arctic root group
Experimental
干预措施: Rhodiola rosea, L (Drug)
Ginseng group
Active Comparator
干预措施: Panax ginseng (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo - dark brown sugar (Drug)
结局指标
主要结局
Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention
时间窗: Over a period of 28 days of treatment
次要结局
- Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).(over a period of 28 days of treatment)
- Quality of Life parameters: changes in quality of life as measured by the SF-36 scale, Danish Stress Profile (SP) test and questions regarding various aspects of well-being as formulated in a non-validated VAS scale(Over a period of 28 days of treatment)
研究者
研究点 (1)
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