Child, Only, COVID-19
Conditions
Brief summary
Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection.
Detailed description
To evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection by shortening the time of first negative turn of virus, improving clinical symptoms and shortening hospital stay, and to observe the safety of Jinzhen oral liquid in clinical application.A total of 240 Patients aged 3 to 18 years old or asymptomatic infected persons who meet the diagnostic criteria for novel coronavirus infection in the COVID-19 Diagnosis and Treatment Protocol (Trial Version 9)were planned to be enrolled. Jinzhen oral liquid was used in the treatment group, and Jinhuaqinggan Granules was used in the control group, with 120 patients in each group. The subjects took the medication for 14 days (the medication could be stopped in advance if they reached the discharge criteria), and were followed up for 14 days after discontinuation. During the treatment period, the subjects' vital signs, chest imaging examination, novel coronavirus nucleic acid test, blood routine, urine routine, liver and kidney function, and condition and symptoms should be monitored on the follow-up day specified in the protocol.
Interventions
DRUGJinzhen oral liquid or Jinhuaqinggan granules
Jinzhen oral liquid, for 3 years old, 10 ml once, twice a day; for 4 to 7 years old, 10 ml a time, 3 times a day; for 8 to 18 years old, 15 ml a time, 3 times a day.The dosage and usage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition. The drugs were medicated for 14 days.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Meet the diagnostic criteria of novel coronavirus infected patients in COVID-19 Diagnosis and Treatment Protocol (Trial Version 9); 2\. Asymptomatic infection or clinical classification of mild or common type; 3\. Aged from 3 to 18 years; 4\. The informed consent process was in accordance with the regulations, and the legal guardian or the children (≥8 years old) signed the informed consent form.
Exclusion criteria
* 1\. Meet the severe/critical early warning indicators; 2\. Children who used proprietary Chinese medicine of the same type for more than 3 days before enrollment; 3\. Children with diarrhea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First negative time of COVID-19 | up to 6 months | First negative time of COVID-19 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness | up to 6 months | Incidence of conversion to severe/critical illness |
| Clinical symptom disappearance rate/time | up to 6 months | Clinical symptom disappearance rate/time |
| The hospitalization time | up to 6 months | The hospitalization time |
Countries
China
Contacts
Primary ContactQian Dong, Professor
Outcome results
None listed