Pediatric Gastrointestinal Cold with Shaoyang Syndrome Pattern
Conditions
Interventions
Control group:10% Children's Xiaochaihu Granules (very low-dose)
Treatment group:Children's Xiaochaihu Granules
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine?
Eligibility
Sex/Gender
All
Age
3 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for pediatric gastrointestinal cold; (2) Conform to the pattern differentiation criteria of Shaoyang syndrome pattern; (3) Aged 3 to 13 years (<14 years); (4) Maximum axillary temperature =37.3°C (99.1°F) within 24 hours prior to randomization; (5) Disease duration =48 hours prior to randomization; (6) The informed consent process complies with regulations, and participants aged =8 years must sign the "Informed Consent Form" together with their guardians.
Exclusion criteria
Exclusion criteria: (1) Patients definitively diagnosed with influenza, rotavirus enteritis, or other specific diseases; (2) Patients with frequent vomiting leading to difficulty in taking medication, or severe diarrhea causing moderate to severe dehydration; (3) Patients with elevated white blood cell count (WBC), absolute neutrophil count (ANC), and C-reactive protein (CRP), deemed by the investigator to indicate bacterial infection; (4) Patients with comorbid or complicated severe malnutrition, rickets, or severe diseases/impairments of the cardiovascular, cerebral, hepatic, renal, or hematopoietic systems; (5) Patients with a history of epilepsy or febrile seizures; (6) Patients with known allergy to the investigational product or its components; (7) Patients considered by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recovery rate/time;Complete fever resolution rate/time;Marked efficacy rate of major symptoms;Response rate of TCM syndrome efficacy/scores;Resolution rate of individual symptoms; | — |
Countries
China
Contacts
Public ContactPingRong
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine?
Outcome results
None listed