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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015827-97 | EudraCT Number |
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To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.
Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PP1 | Experimental | Neurapas balance |
|
| PP2 | Experimental | Pascoflair 425 mg |
|
| PL1 | Placebo Comparator | P-Tabletten weiß |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurapas balance | Drug | 6 tablets single dose |
| |
| Pascoflair 425 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo) | 5 times within 4 h |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline | 5 times within 4 h | |
| Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winfried Wedekind, MD, PhD | Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany | Principal Investigator |
| Wilfried Dimpfel, Prof | Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany | Study Chair |
| Anja Braschoss, MD | Pascoe Pharmazeutische Praeparate GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocode AG | Wetzlar | D-35578 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21810233 | Derived | Dimpfel W, Koch K, Weiss G. Early effect of NEURAPAS(R) balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011 Aug 2;11:123. doi: 10.1186/1471-244X-11-123. |
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| Drug |
3 tablets , single dose |
|
| P-Tabletten weiß | Drug | 3 tablets, single dose |
|
| 5 times wihtin 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6)) | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4) | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect | 5 times within 4 h |