Clinical trial NCT03410862: Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Keywords: Elderberry
Influenza
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Pharmacare Laboratories
First posted: 2018-01-25
Enrollment: 87
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Days Until Alleviation of Flu Symptoms Post Treatment
timeFrame: every 24 hours post study drug administration for minimum of 5 days up to 21 days
measure: Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours
timeFrame: every 24 hours post study drug administration for minimum of 5 days up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: 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.