174: PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01125605
• Collaborator: (none)
• Enrollment: 325
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 64.7

Study Details

Study Description

Brief Summary

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Condition or Disease	Intervention/Treatment	Phase
Nervousness; Sleep Disorders

Detailed Description

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).

Study Design

• Study Type: Observational
• Actual Enrollment: 325 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Adults > 12 years adult patients and patients older than 12 years
Children 6-12 years children between 6 and 12 years
Children 1-6 years children between 1 and 6 years

Outcome Measures

Primary Outcome Measures

1. Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 [begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)]

   The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).

2. Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation [begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)]

   The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

3. Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation [begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)]

   The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

4. Tolerability After Visit 2 and Visit 3 [appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)]

   Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects

Secondary Outcome Measures

1. Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration [begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))]

   The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)

2. Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication [begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))]

   The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

3. Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment [begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))]

   The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

4. Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication [begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))]

   The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

5. Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment [begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))]

   The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).

6. Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) [appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)]

   Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".

7. Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration [appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)]

   Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".

Observational Criteria (=inclusion criteria for documentation):

• Males and females

• Children 1-12 years old

• Adults >12 years old

• suffering from nervous diseases, e.g. sleep disorders due to nervousness.

Exclusion criteria for documentation:

• children younger than 1 year

• no nervous diseases, e.g. sleep disorders due to nervousness.

• no treatment with PASCONAL NERVENTROPFEN

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Multiple German Practices	all over Germany		Germany

Sponsors and Collaborators

• Pascoe Pharmazeutische Praeparate GmbH

Investigators

• Study Director: Bianka Krick, Pascoe Pharmazeutische Praeparate GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
• ClinicalTrials.gov Identifier: NCT01125605
• Other Study ID Numbers: 174A10PNAL
• First Posted: May 18, 2010
• Last Update Posted: Apr 14, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Pascoe Pharmazeutische Praeparate GmbH: PASCONAL; nervousness; nervosity; sleep disorder
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias

Study Results

Participant Flow

Recruitment Details	Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.
Pre-assignment Detail	It was an non-inteventional observational study with 3 visits.

Arm/Group Title	Observational Group
Arm/Group Description	Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
Period Title: Overall Study
STARTED	325
Safety	326
COMPLETED	325
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Observational Group
Arm/Group Description	Pasconal Nerventropfen
Overall Participants	325
Age (Count of Participants)
<=18 years	72 22.2%
Between 18 and 65 years	212 65.2%
>=65 years	41 12.6%
Sex: Female, Male (Count of Participants)
Female	229 70.5%
Male	96 29.5%
Concomitant medication (participants) [Number]
with concomitant medication	176 54.2%
without concomitant medication	149 45.8%
Duration of disease years (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	2.0 (3.8)
State of inclusion diagnosis (participants) [Number]
acute (<= 2 months)	43 13.2%
subchronic/chronic (> 2 months)	163 50.2%
missing data	119 36.6%
Previous treatment of inclusion diagnosis (participants) [Number]
with previous treatment of inclusion diagnosis	245 75.4%
without previous treatment of inclusion diagnosis	80 24.6%

Outcome Measures

1. Primary Outcome

Title	Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
Description	The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Time Frame	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

descriptive; for all partcipations with values at the visits

Arm/Group Title	Visit 1	Visit 2	Visit 3	Last Observation
Arm/Group Description	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at visit 2	Observational group (Pasconal Nerventropfen) at visit 3	Observational group (Pasconal Nerventropfen) at last observation
Measure Participants	325	325	309	325
Mean (Standard Deviation) [units on a scale]	15.8 (6.1)	9.2 (5.6)	5.1 (4.5)	6.2 (5.2)

2. Secondary Outcome

Title	Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
Description	The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)
Time Frame	begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	Visit 1	Last Observation
Arm/Group Description	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at last observation
Measure Participants	325	325
with concomitant medication	15.9 (5.5)	7.7 (5.6)
without concomitant medication	15.7 (6.2)	5.8 (5.0)
< 4 weeks treatment duration	14.3 (5.3)	7.4 (6.0)
>= 4 weeks treatment duration	16.1 (6.2)	5.9 (4.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments	decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	ANCOVA
	Comments	ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments	decrease of the sum score between baseline (visit1) and last observation by duration of treatment
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments	ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate

3. Secondary Outcome

Title	Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
Description	The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Time Frame	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	With Concomitant Medication	Without Concomitant Medication
Arm/Group Description	Observational group (Pasconal Nerventropfen) with concomitant medication	Observational group (Pasconal Nerventropfen) without concomitant medication
Measure Participants	68	240
improved	46 14.2%	206 NaN
unchanged	19 5.8%	32 NaN
worsened	3 0.9%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0014
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
Description	The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Time Frame	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	< 4 Weeks	> = 4 Weeks
Arm/Group Description	Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks	Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
Measure Participants	65	243
improved	46 14.2%	206 NaN
unchanged	16 4.9%	35 NaN
worsened	3 0.9%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0125
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
Description	The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Time Frame	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	With Concomitant Medication	Without Concomitant Medication
Arm/Group Description	Observational group (Pasconal Nerventropfen) with concomitant medication	Observational group (Pasconal Nerventropfen) without concomitant medication
Measure Participants	66	227
improved	43 13.2%	195 NaN
unchanged	21 6.5%	30 NaN
worsened	2 0.6%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
Description	The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Time Frame	begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	< 4 Weeks	> = 4 Weeks
Arm/Group Description	Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks	Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
Measure Participants	61	232
improved	40 12.3%	198 NaN
unchanged	19 5.8%	32 NaN
worsened	2 0.6%	2 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0016
	Comments
	Method	Fisher Exact
	Comments

7. Secondary Outcome

Title	Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
Description	Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Time Frame	appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	With Concomitant Medication	Without Concomitant Medication
Arm/Group Description	Observational group (Pasconal Nerventropfen) with concomitant medication	Observational group (Pasconal Nerventropfen) without concomitant medication
Measure Participants	68	174
PASCONAL better	40 12.3%	128 NaN
No difference	18 5.5%	34 NaN
PACONAL worse	10 3.1%	12 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0504
	Comments
	Method	Fisher Exact
	Comments

8. Primary Outcome

Title	Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
Description	The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Time Frame	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

descriptive; for all partcipations with values at the visits

Arm/Group Title	Visit 1	Visit 2	Visit 3	Last Observation
Arm/Group Description	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at visit 2	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at last observation
Measure Participants	308	306	293	308
0=not present	0 0%	23 NaN	78 NaN	79 NaN
1=mild	63 19.4%	171 NaN	180 NaN	789 NaN
2=moderate	166 51.1%	98 NaN	26 NaN	29 NaN
3=Strong	79 24.3%	14 NaN	9 NaN	11 NaN

9. Secondary Outcome

Title	Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
Description	Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Time Frame	appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

exploratively, all participations with values

Arm/Group Title	< 4 Weeks	>= 4 Weeks
Arm/Group Description	Observational group (Pasconal Nerventropfen) with concomitant medication	Observational group (Pasconal Nerventropfen) without concomitant medication
Measure Participants	52	190
PASCONAL better	25 7.7%	143 NaN
No difference	16 4.9%	36 NaN
PACONAL worse	11 3.4%	11 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Visit 1, Visit 2
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Fisher Exact
	Comments

10. Primary Outcome

Title	Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
Description	The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Time Frame	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

descriptive; for all partcipations with values at the visits

Arm/Group Title	Visit 1	Visit 2	Visit 3	Last Observation
Arm/Group Description	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at visit 2	Observational group (Pasconal Nerventropfen) at visit 1	Observational group (Pasconal Nerventropfen) at last observation
Measure Participants	293	291	278	293
0=not present	0 0%	41 NaN	111 NaN	115 NaN
1=mild	86 26.5%	163 NaN	136 NaN	142 NaN
2=moderate	140 43.1%	72 NaN	25 NaN	27 NaN
3=Strong	67 20.6%	15 NaN	6 NaN	9 NaN

11. Primary Outcome

Title	Tolerability After Visit 2 and Visit 3
Description	Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects
Time Frame	appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

Outcome Measure Data

Analysis Population Description

descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured

Arm/Group Title	Visit 2	Visit 3
Arm/Group Description	Observational group (Pasconal Nerventropfen) at visit 2	Observational group (Pasconal Nerventropfen) at visit 3
Measure Participants	326	326
well tolerated	313 96.3%	303 NaN
poor tolerated	13 4%	23 NaN

Adverse Events

Time Frame	after appr. 2 weeks and after appr. 4 weeks
Arm/Group Title	Observational Group
Arm/Group Description	Pasconal Nerventropfen
All Cause Mortality
	Observational Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Observational Group
	Affected / at Risk (%)	# Events
Total	0/326 (0%)
Other (Not Including Serious) Adverse Events
	Observational Group
	Affected / at Risk (%)	# Events
Total	14/326 (4.3%)
Cardiac disorders
tachycardia	1/326 (0.3%)	1
Gastrointestinal disorders
gastrointestinal	2/326 (0.6%)	2
nausea	2/326 (0.6%)	2
heartburn	1/326 (0.3%)	1
stomach ache	1/326 (0.3%)	1
tongue and mucosa under tongue	1/326 (0.3%)	1
General disorders
tiredness	3/326 (0.9%)	3
Nervous system disorders
headache	2/326 (0.6%)	2
Psychiatric disorders
aggressivity	1/326 (0.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.