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

NCT02654158 | Completed DMC

• 1 other identifier: 2013Pro234.EKZY
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Upper Respiratory Infection

Keywords

acute upper respiratory infection

Outcome Measures

Primary Outcomes (1)

• Duration of cold symptoms

  Cold diagnostic criteria： 1. Nasal congestion, runny nose, sneezing, itchy throat, or pain, cough 2. The chills, fever, no sweat or less sweat, headache, limb sour 3. The total numbers of normal or low white blood cells, neutropenia, relative increase in lymphocytes. Cold cure criteria: 1. Fever, aversion to wind individual symptoms disappeared 2. 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

Study Arms (2)

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

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

Interventions

Low-dose of Fuganlin Oral Liquid DRUG

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

Also known as: No other names

Low-dose of Fuganlin Oral Liquid

High-dose of Fuganlin Oral Liquid DRUG

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

Also known as: No other names

High-dose of Fuganlin Oral Liquid

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 440100, China

Location

Study Officials

• Li xinmin, PhD

  The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine

  STUDY CHAIR

• 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

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

• Mou qinghui, MD

  Jinan children's hospital

  PRINCIPAL INVESTIGATOR

• Liu yulin, MD

  BoAi Hospital of Zhongshan

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: August 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2016-01

Locations

CN (1)