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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2019-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

NCT01980966

Healthy Volunteer

COMPLETED PHASE2

Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

NCT04610047

Influenza Influenza -Like Illness

COMPLETED PHASE2

Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults

NCT01314911

Influenza, Human

COMPLETED NA

Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

NCT04043923

Influenza -Like Illness

COMPLETED PHASE2

Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza

NCT01740063

Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza, Human

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elderberry Extract

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.

Group Type EXPERIMENTAL

Elderberry Extract

Intervention Type DRUG

Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elderberry Extract

Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)

Intervention Type DRUG

Placebos

Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sambucol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No