Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection.
Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms.
Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication.
Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Beer Sheba、以色列
- 招聘中
- Revivim and Mashabei Sadeh Clalit Clinics
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接触：
- Yael Peleg, MA
- 电话号码：972-8-6479941
- 邮箱：ypeleg@bgu.ac.il
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接触：
- Assi Cicurel
- 电话号码：972-54-2401500
- 邮箱：cicurels@gmail.com
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首席研究员：
- Assi Cicurel, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Exclusion Criteria:
- Evidence of the bacterial infection
- Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
- Hospitalisation is planned
- Surgery within previous 2 months
- Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
- Subject with known renal dysfunction (creatinine ≥ 2 mg/dL)
- Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN
- Participation in the active follow-up phase of another clinical study of an investigational drug or device
- Known hypercalcemia -
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Food supplement
Half of the subjects participating in the trial (91) will recieve four tablets of the food supplement (Gardemont Goldrain Plus) three times a day for seven consecutive days from inclusion.
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Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Global Assessment (PGA)
大体时间：Seven days
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Patient global assessment (PGA) will be a primary measurement, based on the self-reporting answer to the following question: "What is your overall feeling as compared to the first day of treatment: worse, same or better".
Time from the enrollment to the first 12 hours when the subject reports on a sustained improvement in symptoms (two consequent 12 hours periods) will be a primary outcome.
The study supplement administration will be continued for 7 days.
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Seven days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of safety composite
大体时间：30 days
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Death, hospitalizations, serious adverse effects
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30 days
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合作者和调查者
调查人员
- 研究主任：Zvi Bentwich, MD、Ben-Gurion University of the Negev
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Gardemont Goldtrain Plus (GT+)的临床试验
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Children's Oncology GroupNational Cancer Institute (NCI)主动，不招人