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

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

Study Overview

• Status: Completed
• Conditions: Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Low-dose of Fuganlin Oral Liquid; Drug: High-dose of Fuganlin Oral Liquid

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.

• Study Type: Observational
• Enrollment (Actual): 2400

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 440100
      • Guangdong Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged 1 to 12 years old with acute upper respiratory infection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low-dose of Fuganlin Oral Liquid; oral 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: 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; Other Names: No other names
High-dose of Fuganlin Oral Liquid; oral 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	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; Other Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of cold symptoms	Cold diagnostic criteria： Nasal congestion, runny nose, sneezing, itchy throat, or pain, cough; The chills, fever, no sweat or less sweat, headache, limb sour; The total numbers of normal or low white blood cells, neutropenia, relative increase in lymphocytes. Cold cure criteria: Fever, aversion to wind individual symptoms disappeared; Nasal congestion, runny nose, sore throat, cough individual symptoms disappeared	Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days

Collaborators and Investigators

• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Investigators: Study Chair: Li xinmin, PhD, The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine; Principal Investigator: Chang ke, MD, Chengdu University of Traditional Chinese Medicine; Principal Investigator: Meng qingping, MD, Zhengzhou Children'S Hospital; Principal Investigator: Tao lei, MD, Huanggang Maternal and Child Health Hospital; Principal Investigator: Ding ying, MD, Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese Medicine; Principal Investigator: Xiang xixiong, PhD, Hubei Hospital of Traditional Chinese Medicine; Principal Investigator: Cheng ji, MD, Second Affiliated Hospital of Wenzhou Medical University; Principal Investigator: Ying yong, MD, Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine; Principal Investigator: Liu changshan, MD, Second Hospital of Tianjin Medical University; Principal Investigator: Mou qinghui, MD, Jinan Children's Hospital; Principal Investigator: Liu yulin, MD, Zhongshan Boai Hospital; Principal Investigator: Wang lisheng, PhD, Shenzhen Children's Hospital; Principal Investigator: Zhao deyu, PhD, Affiliated Nanjing Children's Hospital of Nanjing Medical University; Principal Investigator: Du yonggang, MD, Changzhi People's Hospital; Principal Investigator: Su baoling, MD, Affiliated Heji Hospital of Changzhi Medical College; Principal Investigator: Qing yanhong, MD, Affiliated Hospital of Shanxi College of Traditional Chinese medicine; Principal Investigator: Cheng zhimin, PhD, Affiliated Children's Hospital of Zhejiang University School of Medicine; Principal Investigator: Lin yan, MD, Chengdu Women and Children's Hospital; Principal Investigator: Xu youjia, MD, Guangdong Provincial Hospital of Traditional Chinese Medicine; Principal Investigator: Zhang mingying, MD, Beijing Shunyi Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: acute upper respiratory infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2013Pro234.EKZY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED