Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection
A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Mar 2022
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2022
CompletedFirst Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2023
CompletedAugust 19, 2022
August 1, 2022
6 months
August 17, 2022
August 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
First negative time of COVID-19
First negative time of COVID-19
up to 6 months
Secondary Outcomes (3)
Clinical symptom disappearance rate/time
up to 6 months
The hospitalization time
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
up to 6 months
Study Arms (2)
treatment group
EXPERIMENTALJinzhen 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)
control group
ACTIVE COMPARATORThe usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully
Interventions
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 Criteria
You may qualify if:
- \. Meet the diagnostic criteria of novel coronavirus infected patients in COVID-19 Diagnosis and Treatment Protocol (Trial Version 9);
- \. Asymptomatic infection or clinical classification of mild or common type;
- \. Aged from 3 to 18 years;
- \. 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.
You may not qualify if:
- \. Meet the severe/critical early warning indicators;
- \. Children who used proprietary Chinese medicine of the same type for more than 3 days before enrollment;
- \. Children with diarrhea.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phase I Clinical Research Center
Qingdao, Shandong, 266003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 19, 2022
Study Start
March 18, 2022
Primary Completion
September 10, 2022
Study Completion
March 17, 2023
Last Updated
August 19, 2022
Record last verified: 2022-08