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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27842378

Enrollment

Registered

2010-07-19

Start date

2010-06-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

One tablet of 500 mg Sokatin® per day in the morning for eight weeks. The intake phase will be eight weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026