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

• ClinicalTrials.gov Identifier: NCT03410862
• Recruitment Status: Completed
• First Posted: January 25, 2018
• Results First Posted: January 19, 2021
• Last Update Posted: January 19, 2021
• Sponsor: michael macknin
• Collaborator: Pharmacare Laboratories
• Information provided by (Responsible Party): michael macknin, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza, Human	Drug: Elderberry Extract; Drug: Placebos	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 29, 2018
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: June 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Elderberry Extract; Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry); Other Name: Sambucol
Placebo Comparator: 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.	Drug: Placebos; Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry

Outcome Measures

Primary Outcome Measures :

1. Number of Days Until Alleviation of Flu Symptoms Post Treatment [ Time Frame: every 24 hours post study drug administration for minimum of 5 days up to 21 days ]
   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."
2. Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours [ Time Frame: every 24 hours post study drug administration for minimum of 5 days up to 21 days ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

michael macknin

Pharmacare Laboratories

  Study Documents (Full-Text)

Documents provided by michael macknin, The Cleveland Clinic:

Study Protocol and Statistical Analysis Plan  [PDF] November 8, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: michael macknin, Staff Physician, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03410862
• Other Study ID Numbers: 17-1682
• First Posted: January 25, 2018
• Results First Posted: January 19, 2021
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by michael macknin, The Cleveland Clinic:

Elderberry; Influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases