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Clinical Trials/ISRCTN29449049
ISRCTN29449049
Completed
未知

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

Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites50 target enrollmentMarch 5, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Enrollment
50
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2012
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

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)

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

Outcomes

Primary Outcomes

Not specified

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