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

Study Overview
=================
Brief 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).

Detailed 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.

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

Conditions
-----------------
Acute Upper Respiratory Infection

Intervention / Treatment
-----------------
* Drug: Fuganlin Oral Liquid
* Drug: Xiaoer Jiebiao Oral Liquid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as acute upper respiratory infection. Patients with Traditional Chinese Medicine syndrome of qi deficiency and wind-heat. Patients aged 1 to 12 years. With course of disease in 48 hours or less. Signed informed consent by a Parent or legal guardians. Exclusion Criteria: Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia; Patients have a history of hyperpyretic convulsion; Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases; 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; Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug; According to the doctors' determination,likely to loss to follow up.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fuganlin Oral Liquid<br>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 Xiaoer Jiebiao Oral Liquid placebo:oral 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 | Drug: Fuganlin Oral Liquid<br>* 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<br>* Other names: No other names;|
| Active Comparator: Xiaoer Jiebiao Oral Liquid<br>Xiaoer Jiebiao Oral Liquid:oral 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 Fuganlin Oral Liquid placebo: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 | Drug: Xiaoer Jiebiao Oral Liquid<br>* 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<br>* Other names: No other names;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute upper respiratory infection