This is a multicenter, randomized, open Label, add-on study.
This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms. The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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
RECRUITINGTime 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.
Time frame: Up to Day 12
Duration of Fever
Length of time taken by participants to return to afebrile state
Time frame: Up to Day 12
Signs and Symptoms Score from baseline
(1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate \<30%.
Time frame: Up to Day 12
Usage of antibiotic,hormone and incidence of critical cases
Time frame: Up to Day 12
Time to Cessation of Viral Shedding by RT-PCR
Time frame: Up to Day 12
Relief time of individual symptom such as:expectoration, cough
Time frame: Up to Day 12
Disease efficacy criteria
(1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment.
Time frame: Up to Day 12
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Imaging improvement rate: number of people with normal or baseline imaging
Time frame: Up to Day 12