Nervous Restlessness Clinical Trial
Official title:
Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
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.
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. Data were collected in collaboration
with 22 physicians in Germany.
The study was designed as a one armed non-interventional study. Patients had to suffer from
nervous restlessness in order to be eligible for study documentation. Participants agreed to
a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could
take PASCOFLAIR® at the first time or could have started within the past three months before
the initial visit. Furthermore, documented patients had to be older than 18 years and must
be able to read and understand the patient declaration of data protection and the
declaration of consent. The patient must not be an alcoholic, must not be drug dependent and
have no other types of addiction. Patients who were pregnant or breast-feeding were not
eligible for study participation. Furthermore, patients showing hypersensitivity against
passionflower extract or against other components of the medication were excluded. The
signed declaration of consent of participating patients is available.
The treatment of affected patients may not be documented, if a redemption (written or
spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.
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Observational Model: Cohort, Time Perspective: Prospective