Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza
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|ClinicalTrials.gov Identifier: NCT03410862|
Recruitment Status : Completed
First Posted : January 25, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Drug: Elderberry Extract Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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 [ 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up to 21 days ]Symptoms will be recorded using the scoring system described in a meta-analysis of "all published and unpublished Roche-sponsored randomized placebo-controlled, double-blind trials of oseltamivir treatment in adult influenza" (BMJ 4/9/2014).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."
- 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).
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|Ages Eligible for Study:||5 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410862
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
Documents provided by michael macknin, The Cleveland Clinic:
|Responsible Party:||michael macknin, Staff Physician, The Cleveland Clinic|
|Other Study ID Numbers:||
|First Posted:||January 25, 2018 Key Record Dates|
|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|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases