Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750402.01.026
Study information
Scientific title
Influence of Sokatin® on parameters of the mental and psychic function: An open label, explorative study
Acronym
Study hypothesis
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
Freiburg Ethics Committee (Freiburger Ethik-Kommission) approved on the 10th of May 2010 (ref: 010/1763)
Study design
Single centre open explorative study
Primary study design
Interventional
Secondary study design
Cohort study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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 names
Sokatin®
Primary outcome measures
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
Secondary outcome measures
None
Overall trial start date
15/06/2010
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
15/06/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Am Kleinen Felde 30
Hannover
30167
Germany
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary