ITMCTR2000003173尚未招募4 期
A real-world study on the efficacy and safety of Weichang'an pill in the treatment of rotavirus enteritis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 年龄范围
- 0.5 至 6(—)
- 性别
- All
入选标准
- •1. Age: 6 months (inclusive)-6 years (inclusive);
- •2. Meet the diagnostic criteria of rotavirus enteritis:
- •Fall winter or spring onset;
- •It is most common in infants <2 years old, especially infants <1 year old;
- •The disease first vomiting, then diarrhea, stool for water or egg flower soup, no mucus and pus blood, no odor, stool times more, then the volume is large;
- •Often accompanied by mild respiratory symptoms, such as fever cough runny nose;
- •Prone to dehydration acidosis;
- •Stool assay has adipose bulb only, occasionally see a few leukocyte;
- •Fecal rotavirus antigen tested positive.
- •3. Patients who can eat by mouth;
- •4. The legal guardian of the child subject sign the ICF.
排除标准
- •1. With other types of enteritis other than viral infection;
- •2. Frequent vomiting and inability to eat through the mouth or fast;
- •3. Children with severe dehydration;
- •4. Children with drug allergy in this study;
- •5. Large amounts of white red blood cells (15 per high power microscopic view) can be seen in regular stools;
- •6. With merger of other systemic diseases;
- •7. Those who have participated in other clinical studies in the past 3 months or are participating in clinical studies of other drugs;
- •8. The inestigators determined that there were other conditions that made it inappropriate to participate in the study.
研究者
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