Clinical trial NCT02654158: Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Official title: Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Upper Respiratory Infection
Keywords: acute upper respiratory infection
Lead sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 2400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 1 to 12 years old with acute upper respiratory infection

Brief 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

Detailed description: Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;

High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;

Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.

Research purpose:

1. Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .
2. Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.
3. Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.
4. Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as acute upper respiratory infection.
2. Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.
3. Patients aged 1 to 12 years old.
4. Parents or guardians agreed to participate this study and signed the informed consent.

Exclusion Criteria:

1. Patients whose total numbers of white blood cells around above1.3ULN.
2. Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.
3. Patients allergic to the test drug.
4. Serious cardiovascular, liver,kidney and other primary systemic diseases.
5. Patients should not be included in group according to investigator's evaluation.

Primary outcomes:
measure: Duration of cold symptoms
timeFrame: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine
name: Li xinmin, PhD
role: STUDY_CHAIR
affiliation: Chengdu University of Traditional Chinese Medicine
name: Chang ke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhengzhou Children's Hospital
name: Meng qingping, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huanggang Maternal and Child Health Hospital
name: Tao lei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
name: Ding ying, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Xiang xixiong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Cheng ji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine
name: Ying yong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University Second Hospital
name: Liu changshan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan children's hospital
name: Mou qinghui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Boai Hospital
name: Liu yulin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Children's Hospital
name: Wang lisheng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Nanjing Children's Hospital of Nanjing Medical University
name: Zhao deyu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhi People's Hospital
name: Du yonggang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Heji Hospital of Changzhi Medical College
name: Su baoling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Shanxi College of Traditional Chinese medicine
name: Qing yanhong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Children's Hospital of Zhejiang University School of Medicine
name: Cheng zhimin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chengdu Women and Children's Hospital
name: Lin yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Xu youjia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Shunyi Hospital of China Medical University
name: Zhang mingying, MD
role: PRINCIPAL_INVESTIGATOR
References: