Acute bacterial lower urinary tract infection in children
Conditions
Interventions
Sponsors
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Children aged = 3 years old, among which female children are non-menarche female children; 2. Children with acute bacterial lower urinary tract infection meet the following criteria: ? The patient has no lower urinary tract infection within 3 months, and the onset time is less than 72 hours; ? Clinical manifestations are dysuria, urinary incontinence, frequent urination, urgency, pain of urination, with above symptoms >= 1 and no fever or other systemic symptoms; ? Urine analysis: routine urine examination, white blood cells (high power field) >= 5/HPF in the centrifuged sediment in the middle cleaning section of urine; ? Microscopic smear of urine sediment: non-fungal infection. 3. Meet the diagnostic criteria of traditional Chinese medicine (refer to 2017 guidelines for clinical diagnosis and treatment of pediatric urinary tract infection (revised)) and conform to the TCM syndrome of wet and hot bladder. TCM syndrome of wet and hot bladder: Primary symptoms: urinary frequency stinging, dripping down, yellow urine or turbid urine, abdominal pain, and even pain in the umbilicus. Secondary symptoms: constipation, crying and upset. Tongue and veins: red tongue, thick and greasy yellow fur, slippery pulse. With Primary symptom >= 1 item, refer to the tongue and pulse, TCM syndrome of wet and hot bladder can be diagnosed. 4. Children with independent urination habits and abilities; 5. The legal guardian of the subject shall sign the Subject Informed Consent voluntarily (the subject shall sign at the same time if he/she is over 8 years old).
Exclusion criteria
Exclusion criteria: 1. Exist the symptoms of complicated urinary tract infections such as acute pyelonephritis; 2. Children with upper urinary tract infection with >= 2 infections within 3 months; 3. Previous history of oral cephalosporin allergy; 4. Those who have taken antibiotics within the last week; 5. Children with urinary tract malformations and clear pathogenesis or functional upper/lower urinary tract obstruction or problems by ultrasonic examination; 6. Children with known liver or kidney diseases or who have been diagnosed with epilepsy; 7. Taking or taken drugs that may interact with Chinese herbal medicines; 8. Children with severe malnutrition, mental illness and developmental delay; 9. Those who participated in any clinical trial of drugs or medical devices within 30 days prior to enrollment, or who participated in the trial before; 10. Those who are unable or unwilling to comply with the procedures and restrictions specified by the study; 11. Any situation that the researcher considers will compromise patient safety or data quality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3rd day symptom disappearance rate of dysuria;3rd day symptom disappearance rate of frequent urination;3rd day symptom disappearance rate of urgent urination;3rd day symptom disappearance rate of urinary pain;Curative effect of TCM syndrome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days required for complete symptom relief and normal urine analysis;Antibiotic use rate;Antibiotic use days; | — |
Countries
China
Contacts
Public ContactKai Jiang
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Outcome results
None listed