PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases (174)
This study has been completed.
Sponsor:
Pascoe Pharmazeutische Praeparate GmbH
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01125605
First received: May 10, 2010
Last updated: August 27, 2012
Last verified: August 2012
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Results First Received: July 18, 2012
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
| Conditions: |
Nervousness Sleep Disorders |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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 Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| It was an non-inteventional observational study with 3 visits. |
Reporting Groups
| Description | |
|---|---|
| Observational Group | Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula. |
Participant Flow: Overall Study
| Observational Group | |
|---|---|
| STARTED | 325 [1] |
| Safety | 326 [2] |
| COMPLETED | 325 |
| NOT COMPLETED | 0 |
| [1] | started = had baseline values |
|---|---|
| [2] | 1 patient was only analysed for safety |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Observational Group | Pasconal Nerventropfen |
Baseline Measures
| Observational Group | |
|---|---|
|
Number of Participants
[units: participants] |
325 |
|
Age
[units: participants] |
|
| <=18 years | 72 |
| Between 18 and 65 years | 212 |
| >=65 years | 41 |
|
Gender
[units: participants] |
|
| Female | 229 |
| Male | 96 |
|
Concomitant medication
[units: participants] |
|
| with concomitant medication | 176 |
| without concomitant medication | 149 |
|
Duration of disease years
[units: years] Mean ± Standard Deviation |
2.0 ± 3.8 |
|
State of inclusion diagnosis
[1] [units: participants] |
|
| acute (<= 2 months) | 43 |
| subchronic/chronic (> 2 months) | 163 |
| missing data | 119 |
|
Previous treatment of inclusion diagnosis
[2] [units: participants] |
|
| with previous treatment of inclusion diagnosis | 245 |
| without previous treatment of inclusion diagnosis | 80 |
| [1] | The duration of complaints was divided into two groups to the extent this was possible:
|
|---|---|
| [2] | Within the range of the observational study, it was ascertained whether the inclusion diagnosis had been treated previously. |
Outcome Measures
| 1. Primary: | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] |
| 2. Primary: | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] |
| 3. Primary: | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation [ Time Frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] |
| 4. Primary: | Tolerability After Visit 2 and Visit 3 [ Time Frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) ] |
| 5. Secondary: | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration [ Time Frame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) ] |
| 6. Secondary: | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] |
| 7. Secondary: | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] |
| 8. Secondary: | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication [ Time Frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] |
| 9. Secondary: | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment [ Time Frame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) ] |
| 10. Secondary: | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) [ Time Frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) ] |
| 11. Secondary: | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration [ Time Frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Director of Clinical Trials
Organization: Pascoe pharmazeutische Praeparate GmbH
phone: 0049 641 7960100
e-mail: klinische.forschung@pascoe.de
Organization: Pascoe pharmazeutische Praeparate GmbH
phone: 0049 641 7960100
e-mail: klinische.forschung@pascoe.de
No publications provided
| Responsible Party: | Pascoe Pharmazeutische Praeparate GmbH |
| ClinicalTrials.gov Identifier: | NCT01125605 History of Changes |
| Other Study ID Numbers: | 174A10PNAL |
| Study First Received: | May 10, 2010 |
| Results First Received: | July 18, 2012 |
| Last Updated: | August 27, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |