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

Sponsored by Guangzhou Yipinhong Pharmaceutical CO.,LTD

About this trial

Last updated 9 years ago

Study ID

2012Pro170EKZY

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

1 to 12 Years
All Sexes

Trial Timing

Ended 12 years ago

What is this trial about?

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).

What are the participation requirements?

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.