Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza
| Status: | Recruiting |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 29, 2018 |
| End Date: | May 15, 2020 |
| Contact: | Michael Macknin, MD |
| Email: | MACKNIM@ccf.org |
| Phone: | 216-444-5512 |
Phase IV Study Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza: A Randomized, Double-Blind Placebo-Controlled Trial
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.
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.
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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Edward Maytin, MD
Phone: 216-636-5504
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