Phase IV Study Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza: A Randomized, Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Number of Days Until Alleviation of Flu Symptoms Post Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Elderberry Extract (Drug)
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.
干预措施: Placebos (Drug)
结局指标
主要结局
Number of Days Until Alleviation of Flu Symptoms Post Treatment
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
michael macknin
Staff Physician
The Cleveland Clinic