NCT03410862

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

Phase IV Study Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza: A Randomized, Double-Blind Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: michael macknin · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	Elderberry Extract	Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)
DRUG	Placebos	Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry

Timeline

• Start date: 2018-01-29
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2018-01-25
• Last updated: 2021-01-19
• Results posted: 2021-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study