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A real-world study on the efficacy and safety of Weichang'an pill in the treatment of rotavirus enteritis

A real-world study on the efficacy and safety of Weichang'an pill in the treatment of rotavirus enteritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000031488
Enrollment
Unknown
Registered
2020-04-02
Start date
2020-04-17
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Rotavirus enteritis

Interventions

Sponsors

Jinan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The clinical effect of Weichang'an pill in the treatment of rotavirus enteritis;Safety of Weichang'an pill in the treatment of rotavirus enteritis;

Secondary

MeasureTime frame
To observe the symptom relief time of Weichang'an pill in the treatment of rotavirus enteritis;To evaluate the combined use of Weichang'an pill in the treatment of rotavirus enteritis;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;To explore the factors affecting the efficacy of Weichang'an pill in the treatment of rotavirus enteritis, and establish the optimal medication model;

Countries

China

Contacts

Public ContactWeiwei Zhu

Ji'nan Central Hospital

weiweikeyan@163.com+86 13370582098

Outcome results

None listed

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