A real-world study on the efficacy and safety of Weichang'an pill in the treatment of rotavirus enteritis
- Conditions
- Rotavirus enteritis
- Registration Number
- ITMCTR2000003173
- Lead Sponsor
- Jinan Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Weichang'an pill in the treatment of rotavirus enteritis;The clinical effect of Weichang'an pill in the treatment of rotavirus enteritis;
- Secondary Outcome Measures
Name Time Method To evaluate the combined use of Weichang'an pill in the treatment of rotavirus enteritis;To observe the symptom relief time of Weichang'an pill in the treatment of rotavirus enteritis;To explore the factors affecting the efficacy of Weichang'an pill in the treatment of rotavirus enteritis, and establish the optimal medication model;Digging out the clinical advantages of Weichang'an pill in the treatment of rotavirus enteritis;Wrote and continuously improved the clinical drug recommendations for the treatment of rotavirus enteritis with Weichang'an pill;