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

NCT03410862 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-1682
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderberry; Influenza

Outcome Measures

Primary Outcomes (2)

• 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  Symptoms will be recorded using the scoring system described in a meta-analysis of "all published and unpublished Roche-sponsored randomized placebo-controlled, double-blind trials of oseltamivir treatment in adult influenza" (BMJ 4/9/2014).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

Study Arms (2)

Elderberry Extract

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Elderberry Extract DRUG

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

Also known as: Sambucol

Elderberry Extract

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• michael macknin: lead
• Pharmacare Laboratories: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Macknin M, Wolski K, Negrey J, Mace S. Elderberry Extract Outpatient Influenza Treatment for Emergency Room Patients Ages 5 and Above: a Randomized, Double-Blind, Placebo-Controlled Trial. J Gen Intern Med. 2020 Nov;35(11):3271-3277. doi: 10.1007/s11606-020-06170-w. Epub 2020 Sep 14.

  PMID: 32929634 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

elderberry extract; black elderberry extract

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Outcomes relied solely on self reports of patients' symptoms. We did not subtype the influenza viruses detected in our study and did not check for virus sensitivity to elderberry and to oseltamivir.

Results Point of Contact

• Title: Jeff Negrey Study Coordinator
• Organization: Cleveland Clinic

negreyj2@ccf.org

2166365504

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: January 29, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: January 19, 2021
• Results First Posted: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)