Influence of Sokatin® on parameters of the mental and psychic function
| ISRCTN | ISRCTN27842378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27842378 |
| Secondary identifying numbers | 750402.01.026 |
- 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
Scientific
Am Kleinen Felde 30
Hannover
30167
Germany
Study information
| Study design | Single centre open explorative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Sokatin® |
| Primary outcome measure | 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 study start date | 15/06/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
30167
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
"ROR" |
https://ror.org/043rrkc78 |
|---|
Funders
Funder type
Industry
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
