Influence of Sokatin® on parameters of the mental and psychic functio

Completed

• Conditions: Condition: mild symptoms of exhaustion or fatigue; Signs and Symptoms; Malaise and fatigue

• Registration Number: ISRCTN27842378
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Numerical Analogue Scales: motivation, concentration, exhaustion, resilience and somatic symptoms, measured at baseline, day 7 and weeks 4 and 8<br>2. Multidimensional Fatigue Inventory 20, measured at baseline, day 7 and weeks 4 and 8 <br>3. Global Self-rating of Efficacy, measured at baseline, day 7 and weeks 4 and 8<br>4. SF-36 Health Survey, assessed at weeks 4 and 8<br>5. Sheehan Disability Scale, measured at baseline, day 7 and weeks 4 and 8<br>6. Fatigue Impact Scale, assessed at weeks 4 and 8