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 childre

Phase 4

Recruiting

• Conditions: Acute watery diarrhea

• Registration Number: ITMCTR2100004284
• Lead Sponsor: First Teaching Hospital of Tianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diarrhea curative effect (effective rate);

Secondary Outcome Measures

Name	Time	Method
Duration of diarrhoea (hour);Abdominal pain onset time (day);Rate of disappearance of individual symptoms;Duration of abdominal pain (day);Anti-diarrhea onset time (hour);