Trial | NCT02622659  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    468
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).
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.
Study Started
Mar 31
2012
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Last Update
May 22
2017

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

  • Other names: No other names

Drug 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

  • Other names: No other names

Fuganlin Oral Liquid Experimental

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

Xiaoer Jiebiao Oral Liquid Active Comparator

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

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.
No Results Posted