Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Filtrum-STI, 0,4g Tablets (Produced by AVVA RUS) in Children With Viral Gastroenteritis
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Severity of gastroenteritis
研究概览
简要总结
This is a phase II double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. The drug is not toxic and well combines with other medication
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
- 1 Month 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;
- •72 h or less from the onset of gastrointestinal symptoms.
排除标准
- •severe diseases;
- •individual intolerance of Filtrum-STI
- •treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion
- •treatment with pre- pro- and antibiotics 2 weeks before inclusion
- •participation in other clinical study 1 month before inclusion and during participation in the study.
研究组 & 干预措施
Filtrum-STI
干预措施: Filtrum-STI (lignin hydrolytic) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of gastroenteritis
时间窗: Day 7 after start of the intervention
It's measured by ordinal scales (4- and 5-scores) using data about patients' body temperature, bloating, nausea, abdominal pain, meteorism, stool frequency (physical examination and parent-reported questionnaire).
次要结局
- Intestinal Viruses detection and quantification(Day 10-14 after end of the intervention)
- Secretory IgA(Day 10-14 after end of the intervention)
- Severity of gastroenteritis(Day 10-14 after end of the intervention)
- Scatological examination(Day 10-14 after end of the intervention)
- Dysbacteriosis analysis(Day 7 after start of the intervention)
- Vital functions(Days 1,2,3,4,5,6,7 after start of the intervention and day 10-14 after end of one)
- Blood test(Day 7 after start of the intervention)
- Biochemical blood analysis(Day 7 after start of the intervention)
- Urine analysis(Day 7 after start of the intervention)