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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Criteria

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.