The effect of Rhodiola rosea Extract WS 1375 on attention and mental resource allocation
| ISRCTN | ISRCTN29449049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29449049 |
| Protocol serial number | 578001.01.019 |
| Sponsor | Dr. Willmar Schwabe GmbH & Co. KG (Germany) |
| Funder | Dr Willmar Schwabe GmbH & Co. KG (Germany) |
- Submission date
- 16/02/2012
- Registration date
- 05/03/2012
- Last edited
- 26/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Rhodiola rosea is a traditional herbal medicine. The aim of this study is to look at the possible influence of Rhodiola rosea Extract WS® 1375 on visual attention and mental resource allocation in healthy volunteers at risk of stress.
Who can participate?
Healthy volunteers aged 30 to 50 who work on a computer for at least 15 hours per week
What does the study involve?
All participants take Rhodiola rosea Extract WS 1375 orally for 12 weeks and its effects on attention and dual task performance are assessed.
What are the possible benefits and risks of participating?
Rhodiola rosea extract may relieve symptoms associated with stress such as fatigue and exhaustion, and improve physical and mental work capacities under stressful conditions. There are no reported side effects related to Rhodiola rosea extract.
Where is the study run from?
Universitätsklinikum Schleswig-Holstein (Germany)
When is the study starting and how long is it expected to run for?
March 2012 to July 2013
Who is funding the study?
Dr Willmar Schwabe GmbH & Co. KG (Germany)
Who is the main contact?
Prof. Thomas Münte
Contact information
Scientific
Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Klinik für Neurologie
Ratzeburger Allee 160
Lübeck
23538
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center open-label exploratory trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Single center, open-label clinical trial to study the effects of Rhodiola rosea extract WS 1375 on neuropsychological and neurophysiological measures of attention and mental resource allocation in healthy volunteers |
| Study objectives | To gain initial insight in the possible influence of Rhodiola rosea extract WS 1375 on visual attention and mental resource allocation in healthy subjects at risk for stress symptomatology. |
| Ethics approval(s) | Medical Association of Schleswig-Holstein [Ethik Kommission des Universitätsklinikums Schleswig-Holstein], 14/02/2012, ref: 11-244 |
| Health condition(s) or problem(s) studied | Neuropsychological and neurophysiological measures |
| Intervention | One treatment arm only - Rhodiola rosea Extract WS 1375 (2 x 200mg) administered orally for 12 weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Attention Network Task |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Healthy male or female volunteers aged 30 to 50 years (both inclusive) 2. Signed Informed consent in accordance with the legal requirements 3. Sufficient language skills, readiness, and ability on the part of the subject to comply with the physicians instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter 4. Participants are required to work with a computer at least 15 hrs per week 5. Self-report of occasional visual and mental fatigue during computer work (scores 5 on at least 3 questions of the Ermdung und Computerarbeit questionnaire) |
| Key exclusion criteria | 1. Participation in another experimental drug trial at the same time or within the past 12 weeks before enrollment 2. Current hospitalization of the subject 3. Any clinically significant disease 4. Risk of suicide 5. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within the last 5 years 6. History of Axis I disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) at least one year before enrollment 7. History of head trauma that might be causally related to cognitive impairment 8. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) at least 4 weeks before the study 9. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment 10. Any clinically relevant hepatic, renal (serum creatinine or serum ASAT, ALAT or Gamma GT above 3 times the upper limit of the reference range), cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy), haematologic diseases or thyroid insufficiency, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson's disease, diabetes mellitus 11. Any acute or chronic form of infection including Human immunodeficiency virus (HIV) infection or Lues of any stage (according to medical history or clinical signs and symptoms) 12. Known hypersensitivity to Rhodiola rosea extract 13. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea) 14. Pregnancy, lactation 15. Women capable of childbearing if not using adequate contraception (intra-uterine devices, injectable contraception, oral contraceptives plus one other contraceptive measure) 16.Score of 14 or higher on Beck Depression Inventory II (BDI II) |
| Date of first enrolment | 15/03/2012 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
23538
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 |
Editorial Notes
26/05/2017: Plain English summary added.
