Condition category
Signs and Symptoms
Date applied
08/06/2010
Date assigned
19/07/2010
Last edited
19/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Hahn

ORCID ID

Contact details

Am Kleinen Felde 30
Hannover
30167
Germany

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 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

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

Sponsor information

Organisation

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Sponsor details

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes