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

Summary

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

Conditions

• Influenza in Children

Interventions

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.

Sponsors & Collaborators

• Children's Hospital of Soochow University

  collaborator OTHER

• Anhui Provincial Children's Hospital

  collaborator OTHER

• Qilu Children's Hospital of Shandong University

  collaborator OTHER

• Tianjin 4th Centre Hospital

  collaborator UNKNOWN

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Hebei Maternity&Child Healthcare Hospital

  collaborator UNKNOWN

• The Second Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Yanming Xie, Study Principal Investigator · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2021-06-01

Completion

2021-12-31