Official Title
A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
Brief Summary

Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the controlgroup for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid intreating 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.

Unknown status
COVID-19
Child, Only

Drug: Jinzhen 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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 3 Years ~ Maximum: 18 Years
Countries
China
Locations

Phase I Clinical Research Center
Qingdao, Shandong, China

Investigator: yu Cao, Doctor
Contact: 86-0532-82911767
caoyu@qdu.edu.cn

Contacts

Qian Dong, Professor
0532-82911885
18661801885@163.com

Not Provided

The Affiliated Hospital of Qingdao University
NCT Number
MeSH Terms
COVID-19