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

Acute Upper Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654158
• Other study ID #: 2013Pro234.EKZY
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: May 18, 2017
• Start date: August 2013
• Est. completion date: May 2017

Study information

• Verified date: January 2016
• Source: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

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
• 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

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Yipinhong Pharmaceutical CO.,LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of cold symptoms	Cold diagnostic criteria: Nasal congestion, runny nose, sneezing, itchy throat, or pain, cough; The chills, fever, no sweat or less sweat, headache, limb sour; The total numbers of normal or low white blood cells, neutropenia, relative increase in lymphocytes.; Cold cure criteria: Fever, aversion to wind individual symptoms disappeared; Nasal congestion, runny nose, sore throat, cough individual symptoms disappeared	Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days