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

ISRCTN	ISRCTN27842378
DOI	https://doi.org/10.1186/ISRCTN27842378
Protocol serial number	750402.01.026
Sponsor	Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Funder	Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Submission date: 08/06/2010
Registration date: 19/07/2010
Last edited: 19/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Hahn
Scientific

Am Kleinen Felde 30
Hannover
30167
Germany

Study information

Primary study design	Interventional
Study design	Single centre open explorative study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Influence of Sokatin® on parameters of the mental and psychic function: An open label, explorative study
Study objectives	The objective of the study is to assess the influence of Sokatin on the mental and psychic efficiency in volunteers with mild symptoms of exhaustion or fatigue
Ethics approval(s)	Freiburg Ethics Committee (Freiburger Ethik-Kommission) approved on the 10th of May 2010 (ref: 010/1763)
Health condition(s) or problem(s) studied	Condition: mild symptoms of exhaustion or fatigue
Intervention	One tablet of 500 mg Sokatin® per day in the morning for eight weeks. The intake phase will be eight weeks.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Sokatin®
Primary outcome measure(s)	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
Key secondary outcome measure(s)	None
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key 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 physicians 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
Key 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
Date of first enrolment	15/06/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany

Study participating centre

Am Kleinen Felde 30

Hannover
30167
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes