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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Completed OBSERVATIONAL NCT02654158

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

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.

Interventions

Name: Low-dose of Fuganlin Oral Liquid
Type: DRUG
Description: 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
Name: High-dose of Fuganlin Oral Liquid
Type: DRUG
Description: 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

Primary Outcomes

Measure: Duration of cold symptoms
TimeFrame: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days
Description: 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

Trial Information

NCT ID

NCT02654158

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Guangzhou Yipinhong Pharmaceutical CO.,LTD

Last Updated

December 15, 2025