drugset / Trial / NCT05002179
Echinaforce Study to Investigate Explorative Pharmacology and Effectiveness to Prevent From Enveloped Virus Infections
Phase 4
Completed
122 enrolled
A. Vogel AG
Biodome Clinical · collabBodimed · collabCONVEX CRO · collabMediStat Ltd. · collabPPES lab epigenetic signaling · collabd.s.h. statistical services GmbH · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
It is a single-center, randomized, open-label, phase IV study for the explorative investigation of the pharmacological mode-of-action of Echinaforce® extract in the form of Echinaforce® Chewable tablets"- Further, it is aimed to evaluate the effectiveness of the study product for the prevention and treatment of respiratory tract infections in generally healthy adults following a real-life setting. The study covers 2x2 + 1 month of prevention in 120 randomized participants following a tight sampling set-up for sensitive detection of viral infections by RT-qPCR analysis of nasal swabs and seroconversion of SARS-CoV2 IgG/IgM in serum samples.
Timeline
- Start
- 2020-11-20
- Primary completion
- 2021-05-29
- Completion
- 2021-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Echinacea purpurea | Traditional medicine (herbal / TCM) | 800 mg | — |