Acute Upper Respiratory Infection
Conditions
Keywords
acute upper respiratory infection
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.
Interventions
DRUGXiaoer 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
DRUGFuganlin 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
Sponsors
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The duration of cold symptoms | Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 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 number normal or low of 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 |
Countries
China
Outcome results
None listed