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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004284
Enrollment
Unknown
Registered
2020-10-19
Start date
2020-11-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute watery diarrhea

Interventions

Sponsors

First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 5 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Diarrhea curative effect (effective rate);

Secondary

MeasureTime frame
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);

Countries

China

Contacts

Public ContactLi Xinmin

The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

tjtcmlxm@163.com+86 22-27986368

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026