drugset / Trial / NCT04918771

Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old

NCT04918771 ↗

Phase 3 Completed 435 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The multicenter double-blind placebo-controlled randomized in parallel-group. The objective of this study is to evaluate efficacy and safety of Raphamin in the treatment of acute respiratory viral infection (ARVI) in children aged 12-18 years old.

Timeline

Start
2021-04-29
Primary completion
2023-07-21
Completion
2023-07-21

Outcome

Met primary endpoint

registry analysis (superiority test); Raphamin vs Placebo; p = 0.0003; Mean Difference (Final Values) 1.09 (95% CI 0.51 to 1.67); t-test, 2 sided NCT04918771 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Raphamin Unknown — Oral