The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)

Acute Upper Respiratory Infection Clinical Trial

Official title:

The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622659
• Other study ID #: 2012Pro170EKZY
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2015
• Last updated: May 18, 2017
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2015
• Source: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).

Description:

Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL. Treatment for one week. Patients who were recovered within one week can withdrawal at any time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• 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 Traditional Chinese Medicine syndrome of qi deficiency and wind-heat.

3. Patients aged 1 to 12 years.

4. With course of disease in 48 hours or less.

5. Signed informed consent by a Parent or legal guardians.

Exclusion Criteria:

1. Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia;

2. Patients have a history of hyperpyretic convulsion;

3. Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases;

4. The increased of serum creatinine (Cr), blood urea nitrogen (BUN), alanine aminotransferase (ALT), and urinary protein, urine RBC above "+", which can not use the test illness or possibly combined disease conditions to explain;

5. Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug;

6. According to the doctors' determination,likely to loss to follow up.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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
• Xiaoer Jiebiao Oral Liquid
1~2 years old: 5mL each time and twice a day 3~5 years old: 5mL each time and three times a day 6~14 years old: 10mL each time and twice a day

Locations

Country	Name	City	State
China	Luohe traditional Chinese medicine hospital	Luohe	Henan

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	The 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 number normal or low of 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 3 to 7 days