ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03410862
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Pharmacare Laboratories pharmacare.com.au
Information provided by (Responsible Party):
michael macknin, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Drug: Elderberry Extract Drug: Placebos Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.
Drug: Placebos
Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry




Primary Outcome Measures :
  1. Influenza: Alleviation of Symptoms [ 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 "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."

  2. Influenza: Complete Resolution of All Symptoms for 24 hours [ Time Frame: every 24 hours post study drug administration for minimum of 5 days up to 21 days ]
    Symptom severity score (NONE=0 MILD=1 MODERATE=2 SEVERE=3)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Michael Macknin, MD 216-444-5512 MACKNIM@ccf.org
Contact: Jeffrey Negrey, MA 216-636-5504 negreyj2@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jeff Negrey, MA    216-636-5504    negreyj2@ccf.org   
Principal Investigator: Edward Maytin, MD         
Sub-Investigator: Christine Warren, MD         
Sponsors and Collaborators
michael macknin
Pharmacare Laboratories pharmacare.com.au

Responsible Party: michael macknin, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03410862     History of Changes
Other Study ID Numbers: 17-1682
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
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

Keywords provided by michael macknin, The Cleveland Clinic:
Elderberry
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases