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

NCT ID: NCT02654158


Title
Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
Purpose
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
Details
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.
Conditions
Acute Upper Respiratory Infection
Keywords
acute upper respiratory infection
Source
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Sponsors
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Status
Recruiting
Acronym
Last Updated
13 Feb 2016
URL
Official Link
Locations
China