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

Primary Purpose

COVID-19, Child, Only

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Jinzhen oral liquid or Jinhuaqinggan granules
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Phase I Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group

control group

Arm 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)

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

Outcomes

Primary Outcome Measures

First negative time of COVID-19
First negative time of COVID-19

Secondary Outcome Measures

Clinical symptom disappearance rate/time
Clinical symptom disappearance rate/time
The hospitalization time
The hospitalization time
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

Full Information

First Posted
August 17, 2022
Last Updated
August 17, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05507489
Brief Title
Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection
Official Title
A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Anticipated)
Study Completion Date
March 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Child, Only

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm 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)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully
Intervention Type
Drug
Intervention Name(s)
Jinzhen oral liquid or Jinhuaqinggan granules
Intervention 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.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.
Primary Outcome Measure Information:
Title
First negative time of COVID-19
Description
First negative time of COVID-19
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Clinical symptom disappearance rate/time
Description
Clinical symptom disappearance rate/time
Time Frame
up to 6 months
Title
The hospitalization time
Description
The hospitalization time
Time Frame
up to 6 months
Title
Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness
Description
Incidence of conversion to severe/critical illness
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Dong, Professor
Phone
0532-82911885
Email
18661801885@163.com
Facility Information:
Facility Name
Phase I Clinical Research Center
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yu Cao, Doctor
Phone
86-0532-82911767
Email
caoyu@qdu.edu.cn

12. IPD Sharing Statement

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

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