A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
Sponsor study identifier
interventional
72
1 country
1
Study Start
March 4, 2019
Actual (reported)Primary Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a multicenter, randomized, open Label, add-on study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2019
Actual (reported)May 8, 2019
Actual (reported)May 13, 2019
Actual (reported)March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time to Alleviation of Influenza Signs and Symptoms
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.
Up to Day 12
Duration of Fever
Length of time taken by participants to return to afebrile state
Up to Day 12
Signs and Symptoms Score from baseline
Up to Day 12
Usage of antibiotic,hormone and incidence of critical cases
Up to Day 12
Time to Cessation of Viral Shedding by RT-PCR
Up to Day 12
Relief time of individual symptom such as:expectoration, cough
Up to Day 12
Disease efficacy criteria
Up to Day 12
Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days
Oseltamivir Phosphate treatment for 7-10 days
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
First Submitted
May 8, 2019
First Posted
May 13, 2019
Study Start
March 4, 2019
Actual (reported)Primary Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
March 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 15, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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