Retrospective online survey to investigate user experiences with herbal medicines (phytopharmaceuticals)/PhytoVIS

Study identification

• EU PAS number:
  EUPAS1000000991
• Study ID:
  1000000991
• Official title and acronym:
  Retrospective online survey to investigate user experiences with herbal medicines (phytopharmaceuticals)/PhytoVIS
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  With a few exceptions, phytopharmaceuticals have now become part of self-medication. This makes it difficult or even impossible to track their use by patients and document it. ; So far, there's been little use of the chance to get info on how phytopharmaceuticals are used and tolerated at the point of recommendation. The info collected in Germany on phytopharmaceuticals is currently mostly limited to sales figures and the rather rare reports of adverse drug reactions. ; Against this background, the PhytoVIS project was launched in 2011 with the aim of advancing knowledge in the field of phyto-pharmaceuticals in healthcare. The goal was to develop an online tool that would enable doctors and pharmacists to retrospectively record their patients'/customers' experiences with all herbal preparations available in Germany.; In the previous productive phase of PhytoVIS (EUPAS7082, Study ID 28113), in which 20,000 patients/customers were surveyed on their use of herbal medicines, 24,000 data sets were evaluated. ; The new productive phase of PhytoVIS is intended to supplement the results obtained in the data analyses of the previous productive phase.; The productive phase II is intended to gain further experience with the application of the PhytoVIS tool under real-life conditions. It covers all natural persons who have used phytopharmaceuticals in the last 8 weeks at the time of the survey. The purpose of PhytoVIS is not to collect data on the specific efficacy of phytopharmaceuticals – this is not possible within the framework of observational studies. Rather, the aim is to record how patients assess the effect within the overall therapeutic intervention. This is done in the knowledge that, in addition to the therapeutic interventions, many other influencing factors, such as the spontaneous course of the diseases being treated, play a role. ; The focus should be shifted towards collecting data from children and adolescents, preferably through surveys conducted by paediatricians.
• Study status:
  Planned

Research institutions and networks

Institutions

ClinCompetence Cologne

Institute of Medical Statistics and Computational Biology (IMSB, University of Cologne)

Networks

Kooperation Phytopharmaka

Study timelines

Date when funding contract was signed

Planned:01/08/2024

Actual:15/08/2024

Study start date

Planned:01/07/2025

Data analysis start date

Planned:01/05/2027

Date of final study report

Planned:01/07/2028

Sources of funding

More details on funding

Kooperation Phytopharmaka

Regulatory

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