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Trial record 7 of 15 for:    Passiflora

Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01665170
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : December 9, 2015
Last Update Posted : December 9, 2015
Sponsor:
Collaborator:
Daacro
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Healthy
Stress
Interventions Drug: Passiflora incarnata
Drug: Placebo
Enrollment 60
Recruitment Details Individuals will be recruited via newspaper, mailing lists and radio advertisement in the area of Trier,Germany by DAaCRO. Recruiting: May 2012 - July 2012 in medical center/ CRO for Trier Social Sress Tests.
Pre-assignment Details Three subjects were not included because the recruitment phase was already completed.
Arm/Group Title Placebo Verum
Hide Arm/Group Description Placebo arm, 3 x 1 tablet per every day for 3 days Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
Period Title: Overall Study
Started 30 [1] 30
Bevore TSST 30 30
During TSST 30 30
After TSST 30 30
Completed 30 [2] 30
Not Completed 0 0
[1]
First patient in
[2]
Last TSST/ last patient out
Arm/Group Title Placebo Verum Total
Hide Arm/Group Description Placebo arm Verum arm - Pascoflair 425mg Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
28.57  (5.00) 28.47  (5.81) 28.5  (5.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
15
  50.0%
15
  50.0%
30
  50.0%
Male
15
  50.0%
15
  50.0%
30
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title VAS Insecurity (During)
Hide Description 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.
Time Frame during stress test = Visite 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: mm
56.87  (30.92) 60.93  (30.39)
2.Primary Outcome
Title VAS Anxiety (During)
Hide Description 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.
Time Frame during stress test = Visite 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verum Placebo
Hide Arm/Group Description:
Verum arm - Pascoflair 425mg
Placebo arm
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: mm
29.67  (30.39) 34.17  (30.92)
3.Primary Outcome
Title VAS Stress Perception (During)
Hide Description 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.
Time Frame during stress test = Visite 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: mm
59.20  (28.77) 57.3  (29.42)
4.Secondary Outcome
Title Serum Cortisol (Pre-post Comparison)
Hide Description 2 min. prior to and 1 min. after the TSST
Time Frame 1 day
Outcome Measure Data Not Reported
5.Secondary Outcome
Title ACTH (Pre-post Comparison)
Hide Description ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST
Time Frame 1 day
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Epinephrine (Before)
Hide Description 2 min. prior the TSST
Time Frame 1 day
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Norepinephrine (Before)
Hide Description 2 min. prior the TSST
Time Frame before stress test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: ng/dl
430.29  (121.41) 581.17  (160.82)
8.Secondary Outcome
Title State Anxiety (STAI-X1) Questionnaire
Hide Description 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
Time Frame 1 day
Outcome Measure Data Not Reported
9.Secondary Outcome
Title POMS Questionnaire
Hide Description 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.
Time Frame 1 day
Outcome Measure Data Not Reported
10.Secondary Outcome
Title MDBF Questionnaire
Hide Description 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
Time Frame 1 day
Outcome Measure Data Not Reported
11.Secondary Outcome
Title LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
2.90  (24.23) 11.21  (23.73)
12.Secondary Outcome
Title LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Percent Change
0.63  (25.78) 11.47  (26.83)
13.Secondary Outcome
Title LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Percent Change
3.67  (24.75) -12.53  (23.35)
14.Secondary Outcome
Title LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
1.53  (24.52) 13.38  (26.81)
15.Secondary Outcome
Title LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2, visite 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
5.47  (27.80) 14.59  (28.21)
16.Secondary Outcome
Title LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
-0.33  (28.30) 10.28  (27.23)
17.Secondary Outcome
Title LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
-6.07  (28.28) 1.00  (29.64)
18.Secondary Outcome
Title LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Percent Change
5.63  (26.58) 17.17  (23.90)
19.Secondary Outcome
Title LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percent Change
6.60  (32.92) 19.17  (28.04)
20.Secondary Outcome
Title LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3
Hide Description

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.

Time Frame Visite 2 (before treatment), Visite 3 (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Percent Change
-3.40  (16.53) 1.66  (13.43)
21.Secondary Outcome
Title Norepinephrine (After)
Hide Description 2 min. after the TSST, higher value is better
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: ng/dl
670.11  (204.61) 803.14  (202.05)
22.Secondary Outcome
Title Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)
Hide Description 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.
Time Frame before TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
18.22  (7.66) 22.84  (9.83)
23.Secondary Outcome
Title Sympathovagal Balance (Before TSST, Standing - 2. Measurement)
Hide Description 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.
Time Frame before TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
27.74  (11.05) 33.14  (13.89)
24.Secondary Outcome
Title Sympathovagal Balance (During TSST, Preparation - 3. Measurement)
Hide Description 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.
Time Frame during TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
33.23  (12.21) 38.37  (16.17)
25.Secondary Outcome
Title Sympathovagal Balance (During TSST, Interview - 4. Measurement)
Hide Description 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.
Time Frame during TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
35.94  (13.94) 39.25  (16.56)
26.Secondary Outcome
Title Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)
Hide Description 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.
Time Frame during TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
44.01  (24.35) 45.53  (20.23)
27.Secondary Outcome
Title Sympathovagal Balance (After TSST, Standing - 6. Measurement)
Hide Description 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.
Time Frame after TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
42.36  (21.23) 43.28  (17.71)
28.Secondary Outcome
Title Sympathovagal Balance (After TSST, Sitting - 7. Measurement)
Hide Description 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.
Time Frame after TSST
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Verum
Hide Arm/Group Description:
Placebo arm
Verum arm - Pascoflair 425mg
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: (low frequency/high frequency)*10
26.42  (12.08) 29.93  (13.35)
Time Frame 3 days (during the intake of the medication)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Verum
Hide Arm/Group Description Placebo arm Verum arm - Pascoflair 425mg
All-Cause Mortality
Placebo Verum
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Verum
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Verum
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Gabriele Weiß
Organization: PASCOE pharmazeutische Präparate GmbH
Phone: 0641-7960
Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01665170     History of Changes
Other Study ID Numbers: 178 S11 PF
2011-006129-17 ( EudraCT Number )
First Submitted: August 1, 2012
First Posted: August 15, 2012
Results First Submitted: June 12, 2013
Results First Posted: December 9, 2015
Last Update Posted: December 9, 2015