ISRCTN29449049已完成未知
Single center, open-label clinical trial to study the effects of Rhodiola rosea extract WS 1375 on neuropsychological and neurophysiological measures of attention and mental resource allocation in healthy volunteers
Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 50 人开始时间: 2012年3月5日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Healthy male or female volunteers aged 30 to 50 years (both inclusive)
- •2. Signed Informed consent in accordance with the legal requirements
- •3. Sufficient language skills, readiness, and ability on the part of the subject to comply with the physicians instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter
- •4. Participants are required to work with a computer at least 15 hrs per week
- •5. Self-report of occasional visual and mental fatigue during computer work (scores 5 on at least 3 questions of the Ermdung und Computerarbeit questionnaire)
排除标准
- •1. Participation in another experimental drug trial at the same time or within the past 12 weeks before enrollment
- •2. Current hospitalization of the subject
- •3. Any clinically significant disease
- •4. Risk of suicide
- •5. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within the last 5 years
- •6. History of Axis I disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) at least one year before enrollment
- •7. History of head trauma that might be causally related to cognitive impairment
- •8. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) at least 4 weeks before the study
- •9. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment
- •10. Any clinically relevant hepatic, renal (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range), cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy), haematologic diseases or thyroid insufficiency, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson's disease, diabetes mellitus
- •11. Any acute or chronic form of infection including Human immunodeficiency virus (HIV) infection or Lues of any stage (according to medical history or clinical signs and symptoms)
- •12. Known hypersensitivity to Rhodiola rosea extract
- •13. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
- •14. Pregnancy, lactation
- •15. Women capable of childbearing if not using adequate contraception (intra-uterine devices, injectable contraception, oral contraceptives plus one other contraceptive measure)
- •16.Score of 14 or higher on Beck Depression Inventory II (BDI II)
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