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

Guangzhou Yipinhong Pharmaceutical

Status: Completed

Conditions: Acute Upper Respiratory Infection

Treatments: Drug: High-dose of Fuganlin Oral Liquid; Drug: Low-dose of Fuganlin Oral Liquid

Study type: Observational

Funder types: Industry

Identifiers

NCT02654158

2013Pro234.EKZY

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,400 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,400 participants in 2 patient groups

Low-dose of Fuganlin Oral Liquid

Description:

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

Treatment:

Drug: Low-dose of Fuganlin Oral Liquid

High-dose of Fuganlin Oral Liquid

Description:

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

Treatment:

Drug: High-dose of Fuganlin Oral Liquid