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

Phase 4

Completed

• Conditions: Acute Upper Respiratory Infection
• Interventions: Drug: Fuganlin Oral Liquid; Drug: Xiaoer Jiebiao Oral Liquid

• Registration Number: NCT02622659
• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 468

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuganlin Oral Liquid	Fuganlin Oral Liquid	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	Xiaoer Jiebiao Oral Liquid	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

Primary Outcome Measures

Name	Time	Method
The duration of cold symptoms	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： 1. nasal congestion, runny nose, sneezing, itchy throat, or pain, cough; 2. The chills, fever, no sweat or less sweat, headache, limb sour; 3. The total number normal or low of white blood cells, neutropenia, relative increase in lymphocytes; Cold cure criteria: 1. fever, aversion to wind individual symptoms disappeared; 2. nasal congestion, runny nose, sore throat, cough individual symptoms disappeared

Trial Locations

Locations (1)

Luohe traditional Chinese medicine hospital; 🇨🇳 Luohe, Henan, China