Clinical TrialID 227
Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
NCT01665170
Healthy|Stress
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 227
- Evidence Id
- 227
- Core Evidence Id
- 227
- Source Clinical Trial Id
- 219
- Herb2 Clinical Trial Id
- HBCT000219
- Nct Id
- NCT01665170
- Title
- Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Healthy|Stress
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Passiflora incarnata|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Single_Group
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 60
- Outcome Measure
- VAS Insecurity (During), 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., during stress test = Visite 3|VAS Anxiety (During), 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., during stress test = Visite 3|VAS Stress Perception (During), 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., during stress test = Visite 3
- Sponsor Collaborator
- Pascoe Pharmazeutische Praeparate GmbH|Daacro
- Funded By
- INDUSTRY
- Location
- Juliane Hellhammer, Trier, 54296, Germany
- Other Id
- 178 S11 PF|2011-006129-17
- Start Date
- 2012-05
- Primary Completion Date
- 2012-08
- Completion Date
- 2012-08
- First Posted
- 2012-08-15
- Results First Posted
- 2015-12-09
- Last Update Posted
- 2015-12-09
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01665170
- Title Cn
- Title En
- Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
- Bilingual Status
- semi_complete