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

Qingdao University

Status: Enrolling

Conditions: COVID-19; Child, Only

Treatments: Drug: Jinzhen oral liquid or Jinhuaqinggan granules

Study type: Interventional

Funder types: Other

Identifiers

NCT05507489

JZ-2022-nCoV-0.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

treatment group

Experimental group

Description:

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)

Treatment:

Drug: Jinzhen oral liquid or Jinhuaqinggan granules

control group

Active Comparator group

Description:

The usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully

Treatment:

Drug: Jinzhen oral liquid or Jinhuaqinggan granules