Clinical trial NCT02622659: The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
Official title: The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Upper Respiratory Infection
Keywords: acute upper respiratory infection
Lead sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
Sponsor class: INDUSTRY
First posted: 2015-12-04
Enrollment: 468
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The duration of cold symptoms
timeFrame: Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Luohe
country: China
facility: Luohe traditional Chinese medicine hospital
state: Henan
Study officials:
affiliation: Chongqing First People's Hospital
name: Cao xia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanning maternal and Child Health Hospital
name: Yan yunying, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanchang City Hospital of integrated traditional Chinese and Western Medicine
name: Hu suping, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhou traditional Chinese medicine hospital
name: Wang leping, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liuzhou traditional Chinese medicine hospital
name: Liu Dexing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangyang Central Hospital
name: Qi Shihe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Handan traditional Chinese medicine hospital
name: Ding Lijun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhi City People's Hospital
name: Yang Liping, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Luohe traditional Chinese medicine hospital
name: Feng Ziwei, MD
role: PRINCIPAL_INVESTIGATOR
References: