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.
- Conditions
- Burnout syndrome
- Registration Number
- EUCTR2004-002642-35-SE
- Lead Sponsor
- Green Medicine AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method