Survey on experiences with phytopharmaceuticals via an online based questionnaire (PhytoVIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28113
• EU PAS number:
  EUPAS7082
• Study ID:
  28113
• Official title and acronym:
  Survey on experiences with phytopharmaceuticals via an online based questionnaire (PhytoVIS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Institute of Medical Statistics and Epidemiology (IMSIE Cologne)

Germany

Study timelines

Date when funding contract was signed

Actual: 10/04/2014

Study start date

Planned: 07/07/2014

Actual: 08/07/2014

Data analysis start date

Planned: 01/02/2017

Actual: 01/02/2017

Date of final study report

Planned: 29/12/2017

Actual: 20/02/2018

Sources of funding

Other

More details on funding

Kooperation Phytopharmaka

Study protocol

Initial protocol

2014-0027-Protocol_SDPP_7082

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable