Acute Upper Respiratory InfectionPhase 4NCT02622659
The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
A Phase 4 study testing Fuganlin Oral Liquid and Xiaoer Jiebiao Oral Liquid in people with Acute Upper Respiratory Infection, run by Guangzhou Yipinhong Pharmaceutical CO.,LTD at 1 site in China.
Trial 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). 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?
- Fuganlin Oral Liquid and Xiaoer Jiebiao Oral Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Mar 2014
- Phase
- Phase 4
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Fuganlin Oral Liquid, Xiaoer Jiebiao 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.
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
Xiaoer Jiebiao Oral LiquidDrug
Also called No other names
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
| Study group | Role | What they receive |
|---|---|---|
| Fuganlin Oral Liquid | Experimental | 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 Receives: Drug: Fuganlin Oral Liquid |
| Xiaoer Jiebiao Oral Liquid | Active comparator | 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 Receives: Drug: Xiaoer Jiebiao Oral Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 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 posted4 Dec 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cao xia, MD, Principal investigator, Chongqing First People's HospitalYan yunying, MD, Principal investigator, Nanning maternal and Child Health HospitalHu suping, MD, Principal investigator, Nanchang City Hospital of integrated traditional Chinese and Western MedicineWang leping, MD, Principal investigator, Changzhou traditional Chinese medicine hospitalLiu Dexing, MD, Principal investigator, Liuzhou traditional Chinese medicine hospitalQi Shihe, MD, Principal investigator, Xiangyang Central HospitalDing Lijun, MD, Principal investigator, Handan traditional Chinese medicine hospitalYang Liping, MD, Principal investigator, Changzhi City People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622659
- Sponsor's protocol ID
- 2012Pro170EKZY
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- 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
- The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)
- ClinicalTrials.gov ID
- NCT02622659
- Acronym / sponsor ID
- 2012Pro170EKZY
- Conditions
- Acute Upper Respiratory Infection
- Keywords
- acute upper respiratory infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Guangzhou Yipinhong Pharmaceutical CO.,LTDIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Dec 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuganlin Oral Liquid | Experimental | Drug: Fuganlin Oral LiquidFuganlin 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 | Active comparator | Drug: Xiaoer Jiebiao Oral LiquidXiaoer 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 |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| 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 | Fuganlin Oral Liquid |
| Xiaoer Jiebiao Oral LiquidAlso: No other names1~2 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 | Xiaoer Jiebiao Oral Liquid |
Primary outcome
The 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 3 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 number normal or low of 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.
Cao xia, MD principal investigator
Chongqing First People's Hospital
Yan yunying, MD principal investigator
Nanning maternal and Child Health Hospital
Hu suping, MD principal investigator
Nanchang City Hospital of integrated traditional Chinese and Western Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fuganlin Oral Liquid and Xiaoer Jiebiao Oral Liquid in people with 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 5 inclusion and 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The 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 3 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.