Influenza, Human
Conditions
Keywords
Elderberry, Influenza
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.
Interventions
DRUGElderberry Extract
Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)
DRUGPlacebos
Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry
Sponsors
Pharmacare Laboratories
michael macknin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours | 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). |
| Number of Days Until Alleviation of Flu Symptoms Post Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Elderberry Extract: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry) | 43 |
| 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.
Placebos: Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry | 44 |
| Total | 87 |
Baseline characteristics
| Characteristic | Elderberry Extract | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 18 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 26 Participants | 53 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 16 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) White | 27 Participants | 20 Participants | 47 Participants |
| Region of Enrollment United States | 43 participants | 44 participants | 87 participants |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 38 Participants |
| Sex: Female, Male Male | 27 Participants | 22 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 44 |
| other Total, other adverse events | 4 / 43 | 1 / 44 |
| serious Total, serious adverse events | 1 / 43 | 2 / 44 |
Outcome results
Primary
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.
Time frame: every 24 hours post study drug administration for minimum of 5 days up to 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elderberry Extract | Number of Days Until Alleviation of Flu Symptoms Post Treatment | 5.3 days | Standard Deviation 3.6 |
| Placebo | Number of Days Until Alleviation of Flu Symptoms Post Treatment | 4.9 days | Standard Deviation 2.8 |
Primary
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).
Time frame: every 24 hours post study drug administration for minimum of 5 days up to 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elderberry Extract | Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours | 8.6 days | Standard Deviation 3.9 |
| Placebo | Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours | 8.7 days | Standard Deviation 3.9 |