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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507489
• Other study ID #: JZ-2022-nCoV-0.1
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: August 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: Qian Dong, Professor
• Phone: 0532-82911885
• Email: 18661801885[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 17, 2023
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child, Only
• COVID-19

Intervention

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.

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First negative time of COVID-19	First negative time of COVID-19	up to 6 months
Secondary	Clinical symptom disappearance rate/time	Clinical symptom disappearance rate/time	up to 6 months
Secondary	The hospitalization time	The hospitalization time	up to 6 months
Secondary	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	up to 6 months