Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection

The Affiliated Hospital of Qingdao University240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

COVID-19 Child, Only

Interventions

Jinzhen oral liquid or Jinhuaqinggan granulesDRUG

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

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Phase I Clinical Research Center

Qingdao, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

First negative time of COVID-19

Time frame: up to 6 months

Secondary Outcomes

Clinical symptom disappearance rate/time

Time frame: up to 6 months

The hospitalization time

Time frame: up to 6 months

Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness

Incidence of conversion to severe/critical illness

Time frame: up to 6 months

Central Contacts

Qian Dong, Professor

CONTACT

0532-82911885 18661801885@163.com

Data from ClinicalTrials.gov

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