Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 主要终点
- Reduction in Frequency of Defecation to 3 Times Per Day
研究概览
简要总结
The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
详细描述
Background: Diarrhea is a medical condition characterized by frequent stool, more than 3 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%.
Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed Informed Consent Form for patient's study participation
- •male and female patients at the ages from 18 to 55 years
- •acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool
- •body temperature of ≤ 38 °C
- •patient's ability to adequately cooperate in the process of study
排除标准
- •aged of <18 or >55 years;
- •blood or pus in stool;
- •body temperature of >38 °C;
- •episodes of acute diarrhea for the last 30 days;
- •administration of antidiarrheal products for the last 24 hours;
- •salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi; ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii; ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which require administration of antimicrobial products;
- •pregnancy, lactation;
- •concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results
- •alcoholism and drug abuse;
- •participation in any other clinical study.
研究组 & 干预措施
Carbowhite
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
干预措施: Carbowhite (Drug)
Carbowhite placebo
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
干预措施: Carbowhite placebo (Drug)
结局指标
主要结局
Reduction in Frequency of Defecation to 3 Times Per Day
时间窗: From randomisation up to 5 days
Percent of patients administered the investigational production who achieved the efficacy endpoint (reduction in frequency of defecation to 3 times per day, absence of loose stool) on Day 5 or earlier
次要结局
- Compliance Rate(From randomisation up to 5 days)
- Duration of Treatment(From randomisation up to 5 days)
- Quantity of Used Medication(From randomisation up to 5 days)