NCT04183725

Clinical Study of Reduning Injection for the Treatment of Influenza in Children

Reduning Injection for the Treatment of Influenza in Children:a Randomized, Double-blinded, Parallel-controlled Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety of Reduning injection for the treatment of influenza in children.

Detailed description

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.

Conditions

• Influenza in Children

Interventions

Type	Name	Description
DRUG	Reduning injection	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.
DRUG	Oseltamivir phosphate granules	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-06-01
• Completion: 2021-12-31
• First posted: 2019-12-03
• Last updated: 2019-12-05