Psychological stress MedDRA version: 12 Level: LLT Classification code 10037175 Term: Stress
Conditions
Interventions
Trade Name: Vitano®
Product Name: Vitano Film-coated Tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rhodiola rosea root and rhizome ethanolic extract
Other descriptive name: Vita
Sponsors
University of Surrey
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is able to read and understand the Informed Consent Form (ICF), and understand study procedures. 2. The subject has signed the ICF. 3. Healthy male or female subjects aged 18-35 years inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set. 4. A score above 30 on The State–Trait Anxiety Inventory (STAI-T) 5. The subject agrees to use suitable methods of contraception during the study and for 3 months afterwards. 6. The subject is a non-smoker. 7. The subject is, in the opinion of the investigator, healthy on the basis of medical history, vital signs, and the results of routine laboratory tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant or breast feeding. 2. The subject consumes more than 5 caffeine-containing beverages per day. 3. The subject is colour blind. 4. Clinically significant hepatic or renal abnormality as determined by laboratory tests. 5. BMI above 33. 6. History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit 1. 7. Positive alcohol breath test at any visit. A repeat test will not be allowed. [NOTE: subjects must be told to avoid consumption of alcoholic beverages for at least 24 hours prior to attending the Centre]. 8. Use of any other medication which may interfere with study outcome and/or interfere with IMP within the 2 weeks or 5 half lives preceding the first treatment phase, with the exception of contraceptive pill, non-steroidal analgesics, and paracetamol. [NOTE: Concomitant medications which do not influence study outcome and/or do not interfere with IMP may be allowed at the discretion of the Investigator]. 9.Current participation in another clinical trial with an investigational or non-investigational drug or device, or participation in another clinical trial within the 3 months preceding Visit 1 (screening visit). 10. Any condition that, in the Investigator’s opinion, compromises the subject’s ability to meet protocol requirements or to complete the study. 11. Moderate or severe anxiety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess: • To assess the effectiveness of Vitano® in reducing stress • To assess the impact of Vitano® on cognitive function • To assess the effects of Vitano® on subjective well-being ;Secondary Objective: None;Primary end point(s): The primary outcome measures are: Blood pressure, heart rate, salivary cortisol and subjective rating measures Measures of cognitive function (Simple reaction time, Choice reaction time, Concentration, Speed of thinking, and Cognitive Processing) Measures of subjective well-being. | — |
Countries
United Kingdom
Outcome results
None listed