Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
试验速览
- 阶段
- 2 期
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Patient Global Assessment (PGA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Age eligible (18 ≤ Age ≤ 90)
- •Respiratory infection with or without fever-
排除标准
- •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 -
结局指标
主要结局
Patient Global Assessment (PGA)
时间窗: Seven days
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.
次要结局
- Rate of safety composite(30 days)