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Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02654158
Study type Observational
Source Guangzhou Yipinhong Pharmaceutical CO.,LTD
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date May 2017

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