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

Not Applicable

• Conditions: COVID-19; Child, Only
• Interventions: Drug: Jinzhen oral liquid or Jinhuaqinggan granules

• Registration Number: NCT05507489
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Study Timeline

• Study Start: 2022-03-18
• Status Verified: 2022-08
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19
• Primary Completion: 2022-09-10
• Study Completion: 2023-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Jinzhen oral liquid or Jinhuaqinggan granules	The usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully
treatment group	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)

Primary Outcome Measures

Name	Time	Method
First negative time of COVID-19	up to 6 months	First negative time of COVID-19

Secondary Outcome Measures

Name	Time	Method
Clinical symptom disappearance rate/time	up to 6 months	Clinical symptom disappearance rate/time
The hospitalization time	up to 6 months	The hospitalization time
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

Trial Locations

Locations (1)

Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China