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

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).

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Key information

Conditions

Acute Upper Respiratory Infection

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luohe traditional Chinese medicine hospital

Luohe, Henan, 462000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fuganlin Oral Liquid

Drug

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

Xiaoer Jiebiao Oral Liquid

Drug

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

Primary outcomes

The duration of cold symptoms

Time frame: 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：
- 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

Sponsors and collaborators

Lead sponsor

Guangzhou Yipinhong Pharmaceutical CO.,LTD

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Dec 4, 2015
Registry last updated: May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed