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

Primary Purpose

Acute Upper Respiratory Infection

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fuganlin Oral Liquid
Xiaoer Jiebiao Oral Liquid
Sponsored by
Guangzhou Yipinhong Pharmaceutical CO.,LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Infection focused on measuring acute upper respiratory infection

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Luohe traditional Chinese medicine hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fuganlin Oral Liquid

Xiaoer Jiebiao Oral Liquid

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 16, 2015
Last Updated
May 18, 2017
Sponsor
Guangzhou Yipinhong Pharmaceutical CO.,LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02622659
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Yipinhong Pharmaceutical CO.,LTD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Infection
Keywords
acute upper respiratory infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fuganlin Oral Liquid
Arm Type
Experimental
Arm 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
Arm Title
Xiaoer Jiebiao Oral Liquid
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Fuganlin Oral Liquid
Other Intervention Name(s)
No other names
Intervention Description
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
Intervention Name(s)
Xiaoer Jiebiao Oral Liquid
Other Intervention Name(s)
No other names
Intervention Description
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
Primary Outcome Measure Information:
Title
The duration of cold symptoms
Description
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
Time Frame
Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as acute upper respiratory infection. Patients with Traditional Chinese Medicine syndrome of qi deficiency and wind-heat. Patients aged 1 to 12 years. With course of disease in 48 hours or less. Signed informed consent by a Parent or legal guardians. Exclusion Criteria: Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia; Patients have a history of hyperpyretic convulsion; Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases; 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; Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug; According to the doctors' determination,likely to loss to follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cao xia, MD
Organizational Affiliation
Chongqing First People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan yunying, MD
Organizational Affiliation
Nanning maternal and Child Health Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hu suping, MD
Organizational Affiliation
Nanchang City Hospital of integrated traditional Chinese and Western Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wang leping, MD
Organizational Affiliation
Changzhou traditional Chinese medicine hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liu Dexing, MD
Organizational Affiliation
Liuzhou traditional Chinese medicine hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qi Shihe, MD
Organizational Affiliation
Xiangyang Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ding Lijun, MD
Organizational Affiliation
Handan traditional Chinese medicine hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yang Liping, MD
Organizational Affiliation
Changzhi City People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Ziwei, MD
Organizational Affiliation
Luohe traditional Chinese medicine hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luohe traditional Chinese medicine hospital
City
Luohe
State/Province
Henan
ZIP/Postal Code
462000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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