N/A
Completed N=156
Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
Nervous Restlessness
Source: ClinicalTrials.gov NCT02651922 ↗
Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Change of Symptom Inner Restlessness (Pre - Post) — 137; 3; 6 participants
Summary
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Symptom Inner Restlessness (Pre - Post) |
137; 3; 6 | — |
| SECONDARY Change of Symptom Sleep Disturbance (Pre - Post) |
131; 8; 7 | — |
| SECONDARY Change of Symptom Exhaustion (Pre - Post) |
130; 7; 8 | — |
| SECONDARY Change of Symptom Fear (Pre - Post) |
121; 6; 10 | — |
| SECONDARY Change of Symptom Lack of Concentration (Pre - Post) |
123; 11; 8 | — |
| SECONDARY Change of Symptom Transpiration (Pre - Post) |
106; 9; 6 | — |
| SECONDARY Change of Symptom Nausea (Pre - Post) |
79; 7; 6 | — |
| SECONDARY Change of Symptom Trembling (Pre - Post) |
91; 8; 9 | — |
| SECONDARY Change of Symptom Palpation (Pre - Post) |
117; 9; 4 | — |
| SECONDARY Change of BDEPQ (Benzodiazepine Dependence Questionnaire) |
91; 13; 28 | — |
| SECONDARY Change of RS-13 (Resilience Questionnaire) (Pre - Post) |
115; 3; 14 | — |
| SECONDARY Change in EQ-5D (Health Questionnaire) Scores (Pre - Post) |
104; 22; 7 | — |
| SECONDARY Change of EQ-5D VAS Scores (Pre - Post) |
119; 5; 11 | — |
| SECONDARY Tolerability Assess Using a 5 Point Scale |
109; 35; 2; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- patients suffering from nervous restlessness
Exclusion Criteria
- Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent
- alcoholics, drug pending, addictive disorder
- pregnancy or lactating
- patients showing hypersensitivity against passionflower extract or against other components of the medication
Data sourced from ClinicalTrials.gov (NCT02651922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.