EUCTR2004-002642-35-SE进行中（未招募）不适用
A randomized double-blind placebo-controlled parallel group study of SHR -5 extract of Rhodiola Rosea as adjuvant therapy in patients with stress related fatigue.
Green Medicine AB0 个研究点目标入组 60 人开始时间: 2006年1月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients in the ages 20 to 55, of both sexes. Referred by a physician and subjectively estimating his/her difficulties as equivalent to the criteria for fatigue syndrome” suggested by the National board of health and welfare in Sweden. The ICD-code for fatigue syndrome will be F43.8A from 050101. Criteria in appendix 1. These criteria are more conservative than criteria normally used for burnout”. This will have as a result that all patients included also fulfill criteria for burnout”.
- •In diagnosing subjects ratings on two fatigue scales (Pine’s burnout measure and Karolinska Utbrändhetsskala) Appendix , a symptom rating and additional questions about time and causes in a questionnaire is used. Diagnosis will be made in one of three ways:
- •1.Available information is taken into account by a licensed physician which make the diagnosis on basis of all available information including above mentioned subjective data and written referrals.
- •2.A licensed psychologist meet with the subject for 45 minutes and take into account above mentioned questionnaire and referral. On this basis the psychologist make the diagnosis.
- •3.A licensed physician meet with the subject 30 minutes and take into account above mentioned questionnaire and referral. On this basis the physician make the diagnosis.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Excluded are subjects with co morbidity of other serious diagnosis. Patients with following diagnosis are excluded: heart disease, stroke, insulin-dependent diabetes, cancer, drug addiction and high consumption of alcohol, stomach ulcers, food- and medication-allergy, asthma, psychosis, depressive episode. Excluded are also high nicotine-consumption, pregnancy or lactation.
研究者
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