Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
NCT ID: NCT02654158
Last Updated: 2017-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2400 participants
OBSERVATIONAL
2013-08-31
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
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
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
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
1 Year
12 Years
ALL
No
Sponsors
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Guangzhou Yipinhong Pharmaceutical CO.,LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Li xinmin, PhD
Role: STUDY_CHAIR
The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine
Chang ke, MD
Role: PRINCIPAL_INVESTIGATOR
Chengdu University of Traditional Chinese Medicine
Meng qingping, MD
Role: PRINCIPAL_INVESTIGATOR
Zhengzhou Children's Hospital
Tao lei, MD
Role: PRINCIPAL_INVESTIGATOR
Huanggang Maternal and Child Health Hospital
Ding ying, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese Medicine
Xiang xixiong, PhD
Role: PRINCIPAL_INVESTIGATOR
Hubei Hospital of Traditional Chinese Medicine
Cheng ji, MD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Wenzhou Medical University
Ying yong, MD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine
Liu changshan, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Second Hospital
Mou qinghui, MD
Role: PRINCIPAL_INVESTIGATOR
Jinan children's hospital
Liu yulin, MD
Role: PRINCIPAL_INVESTIGATOR
BoAi Hospital of Zhongshan
Wang lisheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Children's Hospital
Zhao deyu, PhD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Nanjing Children's Hospital of Nanjing Medical University
Du yonggang, MD
Role: PRINCIPAL_INVESTIGATOR
Changzhi People's Hospital
Su baoling, MD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Heji Hospital of Changzhi Medical College
Qing yanhong, MD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Shanxi College of Traditional Chinese medicine
Cheng zhimin, PhD
Role: PRINCIPAL_INVESTIGATOR
Affiliated Children's Hospital of Zhejiang University School of Medicine
Lin yan, MD
Role: PRINCIPAL_INVESTIGATOR
Chengdu Women and Children's Hospital
Xu youjia, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Zhang mingying, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Shunyi Hospital of China Medical University
Locations
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Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2013Pro234.EKZY
Identifier Type: -
Identifier Source: org_study_id
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