A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS Insecurity (During)
研究概览
简要总结
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation
详细描述
Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study information and an informed consent form are handed out. After study inclusion on Visit 2, participants are assigned to one of two groups at random and receive the test products (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of questionnaires regarding wellbeing and the Trier Social Stress Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent;
- •Healthy male and female subjects
- •Non-smoker;
- •Age 25 to 45 years;
- •BMI ≥ 19 to ≤ 30 kg/m2
排除标准
- •Any known allergies to the test substance;
- •Any known addiction to drugs, alcohol or positive results in the drug screening test;
- •Any serious general illness, ongoing or within the last 12 months;
- •Any febrile illness (> 24 hrs.) within 7 days prior to treatment;
- •Any antibiotics for the last four weeks before study inclusion;
- •Diabetes mellitus;
- •Known heart disease, hypertension, kidney disease, significant respiratory disease, epilepsy, or rheumatoid arthritis;
- •Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS) which could place the subject at risk or interfere with the accuracy of the study results;
- •Pregnancy or lactating;
- •Current participation or participation in any type of clinical study in the past week;
- •Current or past participation in a TSST study;
- •Employees of the Sponsor or the CRO;
- •Any other medication that, in the opinion of the Investigator is likely to affect their response to treatment;
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, or haematology as judged by the Investigator;
- •Any other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results.
研究组 & 干预措施
Placebo
Placebo arm
干预措施: Placebo (Drug)
Verum
Verum arm - Pascoflair 425mg
干预措施: Passiflora incarnata (Drug)
结局指标
主要结局
VAS Insecurity (During)
时间窗: during stress test = Visite 3
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
VAS Anxiety (During)
时间窗: during stress test = Visite 3
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
VAS Stress Perception (During)
时间窗: during stress test = Visite 3
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.
次要结局
- Norepinephrine (Before)(before stress test)
- State Anxiety (STAI-X1) Questionnaire(1 day)
- POMS Questionnaire(1 day)
- MDBF Questionnaire(1 day)
- LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- Serum Cortisol (Pre-post Comparison)(1 day)
- ACTH (Pre-post Comparison)(1 day)
- Epinephrine (Before)(1 day)
- LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3(Visite 2, visite 3)
- LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- Sympathovagal Balance (After TSST, Standing - 6. Measurement)(after TSST)
- Sympathovagal Balance (After TSST, Sitting - 7. Measurement)(after TSST)
- LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3(Visite 2 (before treatment), Visite 3 (after treatment))
- Norepinephrine (After)(1 day)
- Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)(before TSST)
- Sympathovagal Balance (Before TSST, Standing - 2. Measurement)(before TSST)
- Sympathovagal Balance (During TSST, Preparation - 3. Measurement)(during TSST)
- Sympathovagal Balance (During TSST, Interview - 4. Measurement)(during TSST)
- Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)(during TSST)