EUCTR2010-022114-12-DE进行中（未招募）不适用
Multizentrische prospektive randomisierte kontrollierte offene Phase IV Studie zur Evaluation von Synergien zwischen WS® 1070 und strukturiertem Stressmanagement bei Patienten mit nachlassender Leistungs- und Konzentrationsfähigkeit sowie Müdigkeits- und Schwächegefühl bei subjektiv erlebter StressbelastungMulticenter, pospective, randomized, controlled, open phase IV study to evaluate synergies between WS® 1070 and a structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress. - WS® 1070 und Stressmanagement
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 135
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
- •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
排除标准
- •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).
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