Asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress
Conditions
Interventions
Trade Name: Eleutherococcus Schwabe Kapseln
Product Code: WS(R) 1070
Pharmaceutical Form: Capsule*
Current Sponsor code: WS(R) 1070
Other descriptive name: Eleutherococcus senticosus dry extract
Conce
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Men and Women aged between 30 and 50 years 2. Written informed consent 3. Fatigue and feeling of weakness proven by a result of more than 6 points in at least 1 sub scale of the “Multidimensional Fatigue Inventory” (MFI-20) 4. Asthenia and decreased concentration capacity proven by a result of more than 8 points in the ASS-SYM questionnaire, sub scale capacity 5. Subjective stress proven by a t-value > 60 in at least 2 scales of the “Trierer Inventar zum Chronischen Stress” (TICS) questionnaire 6. Consultion of all screening results by a medical specialist and attestation that there were no indications of a physical or psychiatric disease as reason for patients afflictions to be found, which required further diagnostics or treatment. 7. In Women of child-bearing potential exclusion of pregnancy and practicing a highly effective method of birth control prior and during study participation:as a) implants or injectables b) combined oral contraceptives c) hormonal IUDs d) two-sided vasectomised partner e) sexual abstinence 8. Willingness and ability to participate in all study specific actions, including the participation in the two-day stress management seminar and the neuropsychological testing at screening, treatment and final visit. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. History of hypersensitivity to one ingredient of the study drug 2. Participation in another clinical trial within 12 weeks prior to study start 3. Pregnancy or breast feeding 4. Diseases, which can affect the absorption of the study drug 5. Severe or acute illnesses within 4 weeks prior to study start 6. Acute or chronic psychiatric (“DSM IV Achse I Störung”) or neurological disorder within 12 months prior to study start 7. Suicidal tendency 8. History of or current substance/ drug abuse 9. Psychotherapy within 12 months prior to study start 10. Concurrent treatment with one substance out of the following substance categories a) Psychotropic drugs b) Hypnotics c) Antiepileptics d) Anti Parkinson drugs e) Anesthetics f) Central active analgesics g) Muscle relaxants h) Herbal medicines or dietary supplements i) Vitamine B compound j) Central active antihypertensives k) Central nervous system antihistamines or antiemetics 11. Clinically significant changes of ECG or laboratory results 12. Clinically significant internistic diseases 13. Planned hospitalization 14. Planned holiday of more than 5 days within study participation 15. Other factors, which could affect study participation (e.g. lack of understanding of study matter and consequences, insufficient language understanding) 16. Treatment with cardio active glycosides 17. Hypertension (RR>140 Hg systolic or >90mm Hg diastolic or antihypertensive treatment) 18. Insulin dependent diabetes mellitus 19. Contraindications for the application of progressive muscle relaxation a) Acute lumbago b) Inflammatory or painful muscle diseases (e.g. myositis) c) Acute arthritides d) Heart failure Other cardiovascular diseases prohibiting the “Valsava-Manöver” (e.g. aortic aneurysm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical trial is an explorative study. There won't be a distinction between primary and secondary objectives. Evaluation of synergies between treatment with WS(R) 1070 and structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress. Tolerability and safety of WS(R) 1070 alone and in combination with structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress.;Secondary Objective: see above;Primary end point(s): The clinical trial is an explorative study. There won't be a distinction between primary and secondary endpoints. • cognitive capacity • physiological stress parameter • subjektive stress • fatigue and feeling of weakness • Alertness, restlessness and mood • quality of life • quality of sleep • physical complaints and activity • therapy contentment • adverse events and health related events | — |
Countries
Germany
Outcome results
None listed