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

michael macknin

Status and phase: Completed; Phase 4

Conditions: Influenza, Human

Treatments: Drug: Elderberry Extract; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03410862

17-1682

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

Elderberry Extract

Experimental group

Description:

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.

Treatment:

Drug: Elderberry Extract

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos