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

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410862
• Other study ID #: 17-1682
• Status: Completed
• Phase: Phase 4
• Start date: January 29, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: January 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• With 48 hours or less of an influenza illness documented by polymerase chain reaction

• Have AT LEAST 2 of the following 7 influenza symptoms (nasal congestion, sore throat, cough, aches and pains, fatigue, headaches, and chills or sweats) graded as either moderate or severe

• Have access to a phone

• Subjects are capable of giving informed consent or have an acceptable legally authorized representative capable of giving consent on the subject's behalf with informed assent given by subject.

• Have been prescribed or offered a prescription for oseltamivir (Tamiflu)

Exclusion Criteria:

• Known allergy to elderberry extract or oseltamivir

• Use of antibiotic or antiviral medication on presentation to the study

• Women who are pregnant, breastfeeding women, or do not agree to appropriate contraception (abstinence, hormonal, intrauterine device, and barrier) to prevent pregnancy during the study.

• Patients with HIV

• Patients with cystic fibrosis

• Patients taking elderberry extract

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Drug:
• Elderberry Extract
Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)
• Placebos
Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
michael macknin	Pharmacare Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days Until Alleviation of Flu Symptoms Post Treatment	Symptoms will be recorded using the scoring system described in a meta-analysis of "all published and unpublished Roche-sponsored randomized placebo-controlled, double-blind trials of oseltamivir treatment in adult influenza" (BMJ 4/9/2014). "The primary outcome will be time to alleviation of all symptoms. Seven influenza symptoms (nasal congestion, sore throat, cough, aches and pains, fatigue, headaches, and chills or sweats)" will be graded by severity as "none/absent" (0), "mild" (1), "moderate" (2), or "severe" (3). Alleviation will be defined to arise when all symptoms scored as absent or mild, and remain so for at least 21.5 hours."	every 24 hours post study drug administration for minimum of 5 days up to 21 days
Primary	Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours	Participants were called daily and asked to report on the severity of their symptoms present. Symptoms graded according to severity score (NONE/ABSENT=0 MILD=1 MODERATE=2 SEVERE=3).	every 24 hours post study drug administration for minimum of 5 days up to 21 days