Status: Finalised First registered on: 17/07/2014
Last updated on: 14/02/2019
1. Study identification
EU PAS Register NumberEUPAS7082
Official titleSurvey on experiences with phytopharmaceuticals via an online based questionnaire
Study title acronymPhytoVIS
Study typeObservational study
Brief description of the studyThis study aims to collect data on application experiences of phytopharmaceuticals. The majority of phytopharmaceuticals in Germany are not covered by the statutory health insurance. Therefore GPs don't have the feasibility to prescribe herbal medicines nor to follow up the treatment. Furthermore the patients' compliance is hardly or not auditable. Data regarding reasons for applying pharmaceuticals, adverse effects or tolerance to herbal medicines are not systematically collected in Germany. PhytoVIS was initiated in order to gain information on the effect experience of patients taking phytompharmaceuticals. The study is not designed to take into account specific subgroups, but to collect data of all natural persons who have been taking herbal medicine during the previous eight weeks on the date of questioning. Amoung others the 'Clinical Global Impression Scale - Efficacy' (GGI-E) questionnaire will be used. Nota bene this study cannot deliver specific proofs on the effectiveness of different drugs. Rather PhytoVIS takes into account the overall effect experience during the therapeutic intervention. Thereby other factors and the course of disease play a role. Concerning adverse events no linkage to causal relationships is possible. Yet all adverse events will be documented and allow a more detailed evaluation. In addition to that data gained on children, pregnant women, and elderly people are valuable, since there are hardly any data available on these subgroups. A secondary endpoint of PhytoVIS is the collection of information on the way of purchase of the medicine as well as on way of recommendation, which will add to the knowledge on health services research. 20 000 data sets will be collected via the online database 'PhytoVIS', that was successfully tested and validated in a pilot phase with 2000 data sets. Natural persons will be questioned at pharmacies.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameInstitute of Medical Statistics and Epidemiology (IMSIE)
Centre locationCologne, Germany
Details of (Primary) lead investigator
Title Professor
Last name Moesges
First name Ralph
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/04/2014
Start date of data collection07/07/201408/07/2014
Start date of data analysis01/02/201701/02/2017
Date of interim report, if expected
Date of final study report29/12/201720/02/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherKooperation Phytopharmaka100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Raskopf
First name Esther
Address line 1Lindenburger Allee 42
Address line 2 
Address line 3 
CityCologne 
Postcode50931 
CountryGermany
Phone number (incl. country code)4922147882923 
Alternative phone number 
Fax number (incl. country code) 
Email address Esther.Raskopf@uni-koeln.de
Public Enquiries
Title Professor 
Last name Moesges 
First name Ralph 
Address line 1Lindenburger Allee 42 
Address line 2 
Address line 3 
CityCologne 
Postcode50931 
CountryGermany 
Phone number (incl. country code)492214783457 
Alternative phone number 
Fax number (incl. country code)004922147882940 
Email address ralph@moesges.de 
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