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

Guangzhou Yipinhong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Acute Upper Respiratory Infection

Treatments: Drug: Xiaoer Jiebiao Oral Liquid; Drug: Fuganlin Oral Liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02622659

2012Pro170EKZY

Details and patient eligibility

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).

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 2 patient groups

Fuganlin Oral Liquid

Experimental group

Description:

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

Treatment:

Drug: Fuganlin Oral Liquid

Xiaoer Jiebiao Oral Liquid

Active Comparator group

Description:

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

Treatment:

Drug: Xiaoer Jiebiao Oral Liquid