NCT02654158

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (actual)
• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Acute Upper Respiratory Infection

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-01-13
• Last updated: 2017-05-22

Locations

1 site across 1 country: China