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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza, Human

Intervention / Treatment
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* Drug: Elderberry Extract
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderberry Extract<br>Patients will be supplied a liquid Elderberry Extract used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days. | Drug: Elderberry Extract<br>* Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)<br>* Other names: Sambucol;|
| Placebo Comparator: Placebo<br>Patients will be supplied a liquid Placebo medication (similar in appearance and taste of Elderberry Extract) used to treat their confirmed human influenza. The dosage of the assigned medication will be 15 ml, or 1 tablespoon. Participants aged 5-12 will be asked to take the medication 2 times per day (morning/night) for a period of 5 days. Participants aged 13 and above will be asked to take the medication 4 times per day (morning/noon/afternoon/night) for a period of 5 days. | Drug: Placebos<br>* Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderberry, Influenza