A Phase 4 interventional study of Elderberry Extract and Placebos in Influenza, Human, sponsored by michael macknin. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by michael macknin · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
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
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 of Sambucus Nigra (Black Elderberry)
Also known as: Sambucol
Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry
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
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
| Milestone | Elderberry Extract | Placebo |
|---|---|---|
| Started | 43 | 44 |
| Completed | 41 | 42 |
| Not completed | 2 | 2 |
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."
| days | Elderberry Extract | Placebo |
|---|---|---|
| Number of Days Until Alleviation of Flu Symptoms Post Treatment | 5.3 ± 3.6 | 4.9 ± 2.8 |
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).
| days | Elderberry Extract | Placebo |
|---|---|---|
| Number of Days Until Complete Resolution of All Flu Symptoms for 24 Hours | 8.6 ± 3.9 | 8.7 ± 3.9 |
Collected over Baseline + 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elderberry Extract | 0/43 (0%) | 1/43 (2.3%) | 4/43 (9.3%) |
| Placebo | 0/44 (0%) | 2/44 (4.5%) | 1/44 (2.3%) |
| Event | Elderberry Extract | Placebo |
|---|---|---|
| HospitalizationGeneral disorders | 1/43 | 2/44 |
| Event | Elderberry Extract | Placebo |
|---|---|---|
| Dry MouthGeneral disorders | 4/43 | 1/44 |
| Age, Categorical(Participants) | Elderberry Extract | Placebo | Total |
|---|---|---|---|
| <=18 years | 16 | 18 | 34 |
| Between 18 and 65 years | 27 | 26 | 53 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Elderberry Extract | Placebo | Total |
|---|---|---|---|
| Female | 16 | 22 | 38 |
| Male | 27 | 22 | 49 |
| Race (NIH/OMB)(Participants) | Elderberry Extract | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 16 | 31 |
| White | 27 | 20 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 8 | 8 |
| Region of Enrollment(participants) | Elderberry Extract | Placebo | Total |
|---|---|---|---|
| United States | 43 | 44 | 87 |
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Plan to share: No — No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
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