drugset / Trial / NCT03410862

Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza

NCT03410862 ↗

Phase 4 Completed 87 enrolled michael macknin Pharmacare Laboratories · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This research is being done to determine if an extract of cooked elderberries will help decrease the duration and severity of influenza symptoms in patients with confirmed influenza. Involvement in this study requires an initial patient screening at the time of their Emergency Department visit in order to confirm eligibility for the study. Once patients have been consented and enrolled as a participant, they will be randomized to take by mouth either Elderberry Extract or a placebo (a similar appearing and tasting liquid without elderberry) for a duration of 5 days. Study information regarding medication adherence, body temperature, symptoms, severity of symptoms, and any possible side effects will be collected from daily phone surveys conducted by the study coordinator. Participation in the study will end after at least 5 days once the patient has not had a temperature above 100°F and has had no influenza symptoms for at least 24 hours, or after 21 days in the study, whichever occurs first.

Timeline

Start
2018-01-29
Primary completion
2019-06-25
Completion
2019-06-25

Outcome

Missed primary endpoint

paper placebo group was 4.9 ± 2.8 days compared to 5.3 ± 3.6 in the elderberry group (p = 0.57). PMID 32929634 ↗

paper We found no evidence that elderberry benefits the duration or severity of influenza. PMID 32929634 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Elderberry Extract Traditional medicine (herbal / TCM) 15 ml Oral

Indications