HealthyPhase 3NCT01665170
Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
A Phase 3 study testing Passiflora incarnata in people with Healthy and Stress, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial summary
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Passiflora incarnata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent;
- Healthy male and female subjects
- Non-smoker;
- Age 25 to 45 years;
- BMI ≥ 19 to ≤ 30 kg/m2
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation
Read the detailed description
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.
- Being tested
- Passiflora incarnata, Placebo
- Keywords
- Pascoflair, tsst, passiflora incarnata, non smoking male, and female volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passiflora incarnataDrug
Also called Pascoflair 425mg coated tablets
3 x 1 tablet per day for 3 days
PlaceboDrug
3 x 1 ablet per day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Placebo |
| Verum | Active comparator | Verum arm - Pascoflair 425mg Receives: Drug: Passiflora incarnata |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: during stress test = Visite 3
Secondary outcomes (25)
Serum Cortisol (Pre-post Comparison)
2 min. prior to and 1 min. after the TSST
Measured: 1 day
ACTH (Pre-post Comparison)
ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST
Measured: 1 day
Epinephrine (Before)
2 min. prior the TSST
Measured: 1 day
Norepinephrine (Before)
2 min. prior the TSST
Measured: before stress test
State Anxiety (STAI-X1) Questionnaire
The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3
Measured: 1 day
POMS Questionnaire
The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = "not at all" to 7 = "very strongly". The questionnaire is completed on V2 and V3.
Measured: 1 day
MDBF Questionnaire
The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = "not at all" to 5 = "very true". To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3
Measured: 1 day
LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2, visite 3
LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.
V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome.
Measured: 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
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.
The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome.
Measured: Visite 2 (before treatment), Visite 3 (after treatment)
Norepinephrine (After)
2 min. after the TSST, higher value is better
Measured: 1 day
Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: before TSST
Sympathovagal Balance (Before TSST, Standing - 2. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: before TSST
Sympathovagal Balance (During TSST, Preparation - 3. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: during TSST
Sympathovagal Balance (During TSST, Interview - 4. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: during TSST
Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: during TSST
Sympathovagal Balance (After TSST, Standing - 6. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: after TSST
Sympathovagal Balance (After TSST, Sitting - 7. Measurement)
Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.
Measured: after TSST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daacro
- Responsible party
- Sponsor
- Investigators
- Michael Clemens, MD, Prof, Principal investigator, Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665170
- Sponsor's protocol ID
- 178 S11 PF
- Other IDs
- 2011-006129-17
- Status last verified
- Nov 2015
- First submitted
- 1 Aug 2012
- Last updated
- 9 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation
- ClinicalTrials.gov ID
- NCT01665170
- Acronym / sponsor ID
- 178 S11 PF
- Keywords
- Pascoflair, tsst, passiflora incarnata, non smoking male, and female volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Daacro
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm |
| Verum | Active comparator | Drug: Passiflora incarnataVerum arm - Pascoflair 425mg |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provide written informed consent;
- Healthy male and female subjects
- Non-smoker;
- Age 25 to 45 years;
- BMI ≥ 19 to ≤ 30 kg/m2
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passiflora incarnataAlso: Pascoflair 425mg coated tablets3 x 1 tablet per day for 3 days | Drug | Verum |
| Placebo3 x 1 ablet per day for 3 days | Drug | Placebo |
Primary outcome
VAS Insecurity (During)
Time frame: 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)
Time frame: 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)
Time frame: 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.
25 secondary outcomes
Serum Cortisol (Pre-post Comparison)
Time frame: 1 day
ACTH (Pre-post Comparison)
Time frame: 1 day
Epinephrine (Before)
Time frame: 1 day
Norepinephrine (Before)
Time frame: before stress test
State Anxiety (STAI-X1) Questionnaire
Time frame: 1 day
POMS Questionnaire
Time frame: 1 day
MDBF Questionnaire
Time frame: 1 day
LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3
Time frame: Visite 2, visite 3
LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3
Time frame: 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
Time frame: Visite 2 (before treatment), Visite 3 (after treatment)
Norepinephrine (After)
Time frame: 1 day
Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)
Time frame: before TSST
Sympathovagal Balance (Before TSST, Standing - 2. Measurement)
Time frame: before TSST
Sympathovagal Balance (During TSST, Preparation - 3. Measurement)
Time frame: during TSST
Sympathovagal Balance (During TSST, Interview - 4. Measurement)
Time frame: during TSST
Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)
Time frame: during TSST
Sympathovagal Balance (After TSST, Standing - 6. Measurement)
Time frame: after TSST
Sympathovagal Balance (After TSST, Sitting - 7. Measurement)
Time frame: after TSST
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Clemens, MD, Prof principal investigator
Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Passiflora incarnata in people with Healthy and Stress, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Insecurity (During) (time frame: during stress test = Visite 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.