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

Completed

• Conditions: Acute Upper Respiratory Infection
• Interventions: Drug: Low-dose of Fuganlin Oral Liquid; Drug: High-dose of Fuganlin Oral Liquid

• Registration Number: NCT02654158
• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

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.

Study Timeline

• Study Start: 2013-08
• Status Verified: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1. Patients diagnosed as acute upper respiratory infection.
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

1. Patients whose total numbers of white blood cells around above1.3ULN.
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose of Fuganlin Oral Liquid	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
High-dose of Fuganlin Oral Liquid	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

Primary Outcome Measures

Name	Time	Method
Duration of cold symptoms	Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days	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 Locations

Locations (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China