A randomized, double-blind, parallel-controlled, multicentre clinical study to evaluate the efficacy and safety of Sechang Zhixie Powder in the treatment of acute watery diarrhea in children

First Teaching Hospital of Tianjin University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patients meeting the diagnostic criteria of acute watery stool diarrhea;
•2. Patients aged 1-5 years (< 6 years);
•3. Patients with diarrhea duration <= 72 hours;
•4. Patients without dehydration or mild or moderate dehydration;
•5. Accompanied with abdominal pain (essential for children over 3 years old);
•6. The process of informed consent should meet the requirements, and the guardian should sign the informed consent.

•1. Patients with invasive bacterial infectious diarrhea / dysentery like diarrhea, such as mucus, purulent stool, or stool microscopic examination found that the number of pus / white blood cells >= 5 / HP and / or red blood cells >= 3 / HP;
•2. Diarrhea caused by special pathogens (such as cholera, dysentery, typhoid), anatomical defects or congenital factors (such as Hirschsprung's disease, malabsorption syndrome), other diseases (such as inflammatory bowel disease, endocrine disease), symptomatic diarrhea, allergic diarrhea, irritable bowel syndrome, antibiotic associated diarrhea, food poisoning, etc;
•3. Patients with severe dehydration, severe malnutrition or edema, frequent vomiting and inability to eat;
•4. Patients with serious primary diseases such as heart, liver, kidney, digestive and hematopoietic system;
•5. Patients who are allergic to the test drug and its components;
•6. The researchers believe that there are any patients who are not suitable for inclusion or have factors affecting the participation or completion of the study.

发起方

First Teaching Hospital of Tianjin University of TCM