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

NCT ID: NCT02622659

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-03-31

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.

Conditions

Acute Upper Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Fuganlin Oral Liquid

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Xiaoer Jiebiao Oral Liquid

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

No other names; No other names

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Yipinhong Pharmaceutical CO.,LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cao xia, MD

Role: PRINCIPAL_INVESTIGATOR

Chongqing First People's Hospital

Yan yunying, MD

Role: PRINCIPAL_INVESTIGATOR

Nanning maternal and Child Health Hospital

Hu suping, MD

Role: PRINCIPAL_INVESTIGATOR

Nanchang City Hospital of integrated traditional Chinese and Western Medicine

Wang leping, MD

Role: PRINCIPAL_INVESTIGATOR

Changzhou traditional Chinese medicine hospital

Liu Dexing, MD

Role: PRINCIPAL_INVESTIGATOR

Liuzhou traditional Chinese medicine hospital

Qi Shihe, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangyang Central Hospital

Ding Lijun, MD

Role: PRINCIPAL_INVESTIGATOR

Handan traditional Chinese medicine hospital

Yang Liping, MD

Role: PRINCIPAL_INVESTIGATOR

Changzhi City People's Hospital

Feng Ziwei, MD

Role: PRINCIPAL_INVESTIGATOR

Luohe traditional Chinese medicine hospital

Locations

Luohe traditional Chinese medicine hospital

Luohe, Henan, China

Countries

China

Other Identifiers

2012Pro170EKZY

Identifier Type: -

Identifier Source: org_study_id