Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The platelet count improvement at 6 days (end of the treatment)
研究概览
简要总结
The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. The duration of this open and randomized phase 2 clinical trial will be 6 days. The estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. The primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute fever of viral etiology with less than 72 hours of progression
- •Signed informed consent.
排除标准
- •Patients under treatment with other antioxidants.
- •Inability to swallow the content of Viusid bags
研究组 & 干预措施
A
Viusid in combination with the conventional treatment for acute fever of viral etiology
干预措施: Viusid (Dietary Supplement)
B
Conventional treatment for acute fever of viral etiology
干预措施: Conventional treatment (Drug)
结局指标
主要结局
The platelet count improvement at 6 days (end of the treatment)
时间窗: 6 days
The leukocyte count improvement at 6 days (end of the treatment)
时间窗: 6 days
The granulocyte count improvement at 6 days (end of the treatment)
时间窗: 6 days
次要结局
- Clinical symptoms disappear during the Viusid administration (6 days).(6 days)
- Adverse effects during treatment(6 days)
- Hemoglobin level improvement(6 days)
- Hematocrit level improvement at 6 days (end of the treatment)(6 days)