The purpose of this study is to evaluate the efficacy, safety of Reduning injection for the treatment of influenza in children.
The clinical efficacy of Traditional Chinese Medicine(TCM) injection was verified by evaluating the efficacy and safety of Reduning injection in the treatment of influenza in children, so as to provide more therapeutic programs for the treatment of influenza in children and provide clinical research evidence for clinical medication.In this study, a parallel control, randomized, double-blind,multi-center trial will be used to design the optimal efficacy of positive drugs.The time of body temperature that return normal was taken as the main therapeutic index.According to the formula of mean superiority test,the number of sample was calculated to 240 cases, with 120 cases in each experimental group and control group.The experimental group was treated with Reduning injection and Oseltamivir phosphate granule simulants, while the control group was treated with Oseltamivir phosphate granules and Reduning injection simulants .Each group will be treated for 5 days.Primary outcome measure this study was mainly from one dimension:Time of temperature recovery.Secondary outcome measures include the time when the fever begins to subside,the time of disease to alleviate,the degree of disease remission,disappearance rate of individual symptoms, etc.Before and after treatment,the temperature of each group was observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Reduning injection: 2≤Age≤5,0.5ml/kg/day,\<10ml/day+5%GS/0.9%NS 50~100ml,iv drip 30~40gtt/min qd\*5; 6≤Age≤10,10ml/day+5%GS/0.9%NS 100~200ml,iv drip 30~60gtt/min qd\*5; 11≤Age≤13,15ml/day+5%GS/0.9%NS 200~250ml,iv drip 30~60gtt/min qd\*5; Age=14,20ml/day+5%GS/0.9%NS 250ml,iv drip 30~60gtt/min qd\*5. Oseltamivir phosphate granules simulants: Weight≤15kg,30mg,po,bid\*5; 15\<Weight≤23kg,45mg,po,bid\*5; 23\<Weight≤40kg,60mg,po,bid\*5; Weight\>40kg,75mg,po,bid\*5.
Oseltamivir phosphate granules: Weight≤15kg,30mg,po,bid\*5; 15\<Weight≤23kg,45mg,po,bid\*5; 23\<Weight≤40kg,60mg,po,bid\*5; Weight\>40kg,75mg,po,bid\*5. +Reduning injection simulants: 2≤Age≤5,0.5ml/kg/day,\<10ml/day+5%GS/0.9%NS 50~100ml,iv drip 30~40gtt/min qd\*5; 6≤Age≤10,10ml/day+5%GS/0.9%NS 100~200ml,iv drip 30~60gtt/min qd\*5; 11≤Age≤13,15ml/day+5%GS/0.9%NS 200~250ml,iv drip 30~60gtt/min qd\*5; Age=14,20ml/day+5%GS/0.9%NS 250ml,iv drip 30~60gtt/min qd\*5.
The time of temperature recovery.
The patients who suffered from influenza were observed their time of temperature recovery .After the first use of the drug,record the time that the patient's temperature dropped to \< 37.3℃.The time required for no recurrence within 24 hours.It was the point that evaluated the end of the treatment.
Time frame: If the subject's temperature is less than 37.3℃ and it isn't maintained rise again for 24 hours within 5 days.
The time when the fever begins to subside
The time required for the first drop of body temperature to reach or exceed 0.5℃.
Time frame: End of day 5.
The time of disease to alleviate
The symptom score of each symptom after treatment is 0 or mild and lasts for more than 24 hours.The symptom score is recorded daily.
Time frame: End of day 5.
The degree of disease remission
According to the"clinical symptom record table", all symptoms were scored.Daily records were recorded to calculate the decrease scores of the total daily symptom score each day.The median time was plotted to calculate Area Under the Curve(AUC) to represent the degree of symptom relief.
Time frame: End of day 5.
The disappearance rate of individual symptoms
After medication,patients were asked to evaluate the presence or disappearance of each symptoms (such as fever, headache, body pain, fatigue, pharynx pain, nasal congestion, runny nose, sweating, thirst, cough) of the Influenza.
Time frame: End of day 5.
The rate of negative conversion of Influenza viral
The baseline and the end point of treatment were tested for influenza virus in pharyngeal swab.
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Time frame: End of day 5.
The number of antipyretic and analgesic drugs used
Evaluate the number of combined antipyretic and analgesic drugs used after medication.
Time frame: End of day 5.
The incidence of severe/complications of influenza
As the end point of the test,collect data of each participants and calculate the incidence rate of severe/complications of influenza.
Time frame: End of day 5.
Frequency of antipyretic and analgesic drugs used
Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.
Time frame: End of day 5.