Influence of Sokatin® on parameters of the mental and psychic function: An open label, explorative study

Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 个研究点目标入组 50 人开始时间: 2010年7月19日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Male and female caucasians aged 30 to 60 years
•2. Written informed consent
•3. Readiness, and ability on the part of the subject to comply with the physician?s instructions
•4. At least 3 of the symptoms listed below assessed as > 5 on NASs:
•4.1. motivation
•4.2. concentration
•4.3. exhaustion
•4.4. resilience
•4.5. somatic symptoms

•1. Concomitant medications:
•1.1. Antidepressives
•1.2. Supplements with ingredients of the test substance
•1.3. Corticosteroids
•1.4. Immunosuppressive agents
•1.5. Non-steroidal anti-inflammatory agents (NSAIDs) within one month before study start
•1.6. Antibiotics within one month before study start
•1.7. Vitamin and mineral nutrients supplement in dosages considerable above the recommended daily allowance
•1.8. Laxatives (regular)
•2. Diagnosed disease considered as cause of exhaustion or fatigue:
•2.1. Chronic infectious diseases
•2.2 Immune mediated diseases
•2.3. Myasthenia
•2.4. Neurological diseases
•2.5. Cardio respiratory diseases
•2.6. Metabolic diseases
•2.7. Psychiatric diseases
•2.8. Severe sleep disorder
•3. Other diseases:
•3.1.Severe chronic diseases
•3.2. Apparent cardio vascular disease
•3.3. Renal insufficiency
•3.4. Liver diseases
•3.5. Chronic disorders of the gastro-intestinal tract
•3.6. Heart surgery
•3.7. Surgery on digestive tract
•3.8. Planned surgery
•4. Pregnancy and lactation
•5. Alcohol and/or substance abuse or dependence
•6. Participation in another experimental trial at the same time or within the past 30 days before enrolment
•7. Known hypersensitivity to ingredients of the test substance

发起方

Dr. Willmar Schwabe GmbH & Co. KG (Germany)