Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection

Summary

Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection

Conditions

• Acute Upper Respiratory Infection

Interventions

DRUG

Low-dose of Fuganlin Oral Liquid

less than 1 years old: 5mL each time and three times a day 1\~3 years old: 10mL each time and three times a day 4\~6 years old: 10mL each time and four times a day 7\~12 years old: 10mL each time and five times a day

DRUG

High-dose of Fuganlin Oral Liquid

less than 1 years old: 10mL each time and three times a day 1\~3 years old: 20mL each time and three times a day 4\~6 years old: 20mL each time and four times a day 7\~12 years old: 20mL each time and five times a day

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD

  lead INDUSTRY

Principal Investigators

• Li xinmin, PhD · The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine

• Chang ke, MD · Chengdu University of Traditional Chinese Medicine

• Meng qingping, MD · Zhengzhou Children's Hospital

• Tao lei, MD · Huanggang Maternal and Child Health Hospital

• Ding ying, MD · Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese Medicine

• Xiang xixiong, PhD · Hubei Hospital of Traditional Chinese Medicine

• Cheng ji, MD · Second Affiliated Hospital of Wenzhou Medical University

• Ying yong, MD · Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine

• Liu changshan, MD · Tianjin Medical University Second Hospital

• Mou qinghui, MD · Jinan children's hospital

• Liu yulin, MD · BoAi Hospital of Zhongshan

• Wang lisheng, PhD · Shenzhen Children's Hospital

• Zhao deyu, PhD · Affiliated Nanjing Children's Hospital of Nanjing Medical University

• Du yonggang, MD · Changzhi People's Hospital

• Su baoling, MD · Affiliated Heji Hospital of Changzhi Medical College

• Qing yanhong, MD · Affiliated Hospital of Shanxi College of Traditional Chinese medicine

• Cheng zhimin, PhD · Affiliated Children's Hospital of Zhejiang University School of Medicine

• Lin yan, MD · Chengdu Women and Children's Hospital

• Xu youjia, MD · Guangdong Provincial Hospital of Traditional Chinese Medicine

• Zhang mingying, MD · Beijing Shunyi Hospital of China Medical University

Eligibility

Min Age

1 Year

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• China

Study Locations