Acute Upper Respiratory InfectionNCT02654158
Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
An observational study of Acute Upper Respiratory Infection, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
Trial summary
Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Acute Upper Respiratory Infection
- What is being tested?
- Low-dose of Fuganlin Oral Liquid and High-dose of Fuganlin Oral Liquid
- Type of treatment
- Pill or oral medicine
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1 to 12 years old with acute upper respiratory infection
Who may be able to join
- Patients diagnosed as acute upper respiratory infection.
- Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.
- Patients aged 1 to 12 years old.
- Parents or guardians agreed to participate this study and signed the informed consent.
Who cannot join
- Patients whose total numbers of white blood cells around above1.3ULN.
- Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.
- Patients allergic to the test drug.
- Serious cardiovascular, liver,kidney and other primary systemic diseases.
- Patients should not be included in group according to investigator's evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 440100
About this study
Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection
Read the detailed description
Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;
High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;
Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.
Research purpose:
- Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .
- Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.
- Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.
- Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.
- Conditions
- Acute Upper Respiratory Infection
- Being tested
- Low-dose of Fuganlin Oral Liquid, High-dose of Fuganlin Oral Liquid
- Keywords
- acute upper respiratory infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose of Fuganlin Oral LiquidDrug
Also called No other names
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
High-dose of Fuganlin Oral LiquidDrug
Also called No other names
less than 1 years old: 10mL each time and three times a day
1~3 years old: 20mL each time and three times a day
4~6 years old: 20mL each time and four times a day
7~12 years old: 20mL each time and five times a day
| Study group | Role | What they receive |
|---|---|---|
| Low-dose of 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 Receives: Drug: Low-dose of Fuganlin Oral Liquid | |
| High-dose of Fuganlin Oral Liquid | oral
less than 1 years old: 10mL each time and three times a day
1~3 years old: 20mL each time and three times a day
4~6 years old: 20mL each time and four times a day
7~12 years old: 20mL each time and five times a day Receives: Drug: High-dose of Fuganlin Oral Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 numbers of normal or low 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
Measured: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li xinmin, PhD, Study chair, The First Affiliated Hospital of Tianjing University of Traditional Chinese MedicineChang ke, MD, Principal investigator, Chengdu University of Traditional Chinese MedicineMeng qingping, MD, Principal investigator, Zhengzhou Children's HospitalTao lei, MD, Principal investigator, Huanggang Maternal and Child Health HospitalDing ying, MD, Principal investigator, Children's Hospital of The First Affiliated Hospital of Henan College of Traditional Chinese MedicineXiang xixiong, PhD, Principal investigator, Hubei Hospital of Traditional Chinese MedicineCheng ji, MD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical UniversityYing yong, MD, Principal investigator, Affiliated Shanghai Children's Medical Center of Shanghai Jiaotong University School of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654158
- Sponsor's protocol ID
- 2013Pro234.EKZY
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Trial,The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Acute Upper Respiratory Infection
- ClinicalTrials.gov ID
- NCT02654158
- Acronym / sponsor ID
- 2013Pro234.EKZY
- Conditions
- Acute Upper Respiratory Infection
- Keywords
- acute upper respiratory infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTDIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IV trial,Single-arm, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with acute upper respiratory infection
Detailed description
Low-dose group of Fuganlin Oral Liquid:dosage from 5 to 10 ml;
High-dose group of Fuganlin Oral Liquid:dosage from 10 to 20 ml;
Treatment for 1 week.Patients who were recovered within 1 week can withdrawal at any time.
Research purpose:
- Evaluate the safety and efficacy of Fuganlin oral Liquid when expanding the designated indications(Qi deficiency wind-heat syndrome to wind-heat syndrome) .
- Explore the relationship between elevated white blood cells and efficacy, age and efficacy, dose and efficacy,While treating with Fuganlin oral Liquid in children with acute respiratory infection.
- Observe the antiviral and immunomodulatory effects of Fuganlin oral Liquid.
- Provide data to support the clinical medicine guidelines and labels amendment of Fuganlin oral Liquid.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose of Fuganlin Oral Liquid | – | Drug: Low-dose of Fuganlin Oral Liquidoral 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 |
| High-dose of Fuganlin Oral Liquid | – | Drug: High-dose of Fuganlin Oral Liquidoral less than 1 years old: 10mL each time and three times a day 1~3 years old: 20mL each time and three times a day 4~6 years old: 20mL each time and four times a day 7~12 years old: 20mL each time and five times a day |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 to 12 years old with acute upper respiratory infection
Key inclusion criteria (4 listed)
- Patients diagnosed as acute upper respiratory infection.
- Patients with acute upper respiratory infection diagnosed as Tradition Chinese Medicine syndrome qi deficiency wind-heat.
- Patients aged 1 to 12 years old.
- Parents or guardians agreed to participate this study and signed the informed consent.
Key exclusion criteria (5 listed)
- Patients whose total numbers of white blood cells around above1.3ULN.
- Patients diagnosed as suppurative tonsillitis, otitis media, bronchitis and other airway.
- Patients allergic to the test drug.
- Serious cardiovascular, liver,kidney and other primary systemic diseases.
- Patients should not be included in group according to investigator's evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose of Fuganlin Oral LiquidAlso: No other namesless 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 | Low-dose of Fuganlin Oral Liquid |
| High-dose of Fuganlin Oral LiquidAlso: No other namesless than 1 years old: 10mL each time and three times a day 1~3 years old: 20mL each time and three times a day 4~6 years old: 20mL each time and four times a day 7~12 years old: 20mL each time and five times a day | Drug | High-dose of Fuganlin Oral Liquid |
Primary outcome
Duration of cold symptoms
Time frame: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 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 numbers of normal or low 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li xinmin, PhD study chair
The First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine
Chang ke, MD principal investigator
Chengdu University of Traditional Chinese Medicine
Meng qingping, MD principal investigator
Zhengzhou Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Upper Respiratory Infection, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of cold symptoms (time frame: Defined as the time from the onset of the cold to the time achieve a cold cure standard,time average 1 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.