NCT01411709已完成4 期
A Pilot Study On The Effect Of Vitano® On Physiological And Psychological Responses To Psychological Stress Assessed Under Laboratory Conditions And In Everyday Life
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood pressure measurements
研究概览
简要总结
A pilot investigation into the stress relieving properties of Vitano® which will assess the following hypotheses
Individuals exposed to Vitano® will demonstrate diminished blood pressure and heart rate responses to mental stress compared to individuals in the control condition
Physiological recovery (BP, HR and cortisol) from mental stress will be enhanced in individuals exposed to Vitano® compared to individuals in the control condition
Vitano® will have positive effects on cognitive functioning.
Subjective ratings of stress will be reduced in individuals exposed to Vitano® compared to individuals in the control condition
There will be a significant improvement in subjective well-being in individuals taking Vitano®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- •The subject has signed the ICF.
- •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.
- •A score above 30 on the Spielberger State-Trait Anxiety Inventory (STAI).
- •The subject agrees to use suitable methods of contraception during the study and for 3 months afterwards.
- •The subject is a non-smoker.
- •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.
排除标准
- •The subject is pregnant or breast feeding.
- •The subject consumes more than 5 caffeine-containing beverages per day.
- •The subject is colour blind.
- •Clinically significant hepatic or renal abnormality as determined by laboratory tests.
- •BMI above
- •History of alcohol, narcotic, benzodiazepine, or other substance abuse or dependence within the 12 months preceding Visit
- •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].
- •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].
- •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).
- •Any condition that, in the Investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
- •Moderate or severe anxiety* *If participants are found to have moderate or severe anxiety during the screening process then they will be referred to the University Counselling service.
研究组 & 干预措施
Vitano
Active Comparator
干预措施: Vitano (Drug)
结局指标
主要结局
Blood pressure measurements
时间窗: Measurements over 14 days (Day 0, Day 7 and Day 14)
Blood pressure readings taken under laboratory conditions during cognitive testing and relaxation periods
次要结局
- Measures of cognitive function(14 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 DiabetesType 1 DiabetesNCT01390480Medical University of Graz31
已完成
不适用
A pilot study for the VITAL trial (Vitamins and Aspirin for the Treatment of Dementia)ervous system diseases: DementiaNervous System DiseasesDementiaISRCTN30537186HS R&D Regional Programme Register - Department of Health (UK)
尚未招募
不适用
Pilot intervention study aimed at reducing stress in parents of children undergoing SCTbeenmergtransplantatiecancer stem cell transplantation10024324NL-OMON32023Academisch Medisch Centrum40
招募中
不适用
The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.HPV InfectionNCT06285357Lo.Li.Pharma s.r.l100
已完成
不适用
Pilot study to look at the physiological response to walking on a treadmill with Nordic poles of patients with intermittent claudication of the lower limbCardiovascular: Intermittent claudicationCirculatory SystemIntermittent claudicationISRCTN21809551Record Provided by the NHSTCT Register - 2007 Update - Department of Health15