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).

Study Overview

• Status: Completed
• Conditions: Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Fuganlin Oral Liquid; Drug: Xiaoer Jiebiao Oral Liquid

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 Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Luohe, Henan, China, 462000
      • Luohe traditional Chinese medicine hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: No other names
Active Comparator: 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	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; Other Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of cold symptoms	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	Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days

Collaborators and Investigators

• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Investigators: Principal Investigator: Cao xia, MD, Chongqing First People's Hospital; Principal Investigator: Yan yunying, MD, Nanning maternal and Child Health Hospital; Principal Investigator: Hu suping, MD, Nanchang City Hospital of integrated traditional Chinese and Western Medicine; Principal Investigator: Wang leping, MD, Changzhou traditional Chinese medicine hospital; Principal Investigator: Liu Dexing, MD, Liuzhou traditional Chinese medicine hospital; Principal Investigator: Qi Shihe, MD, Xiangyang Central Hospital; Principal Investigator: Ding Lijun, MD, Handan traditional Chinese medicine hospital; Principal Investigator: Yang Liping, MD, Changzhi City People's Hospital; Principal Investigator: Feng Ziwei, MD, Luohe traditional Chinese medicine hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: acute upper respiratory infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2012Pro170EKZY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED