Handfoot-mouth DiseasePhase 4NCT02328651
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
A Phase 4 study testing Ribavirin plus Xiao'er jiebiao oral liquid and Ribavirin in people with Handfoot-mouth Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Handfoot-mouth Disease
- What is being tested?
- Ribavirin plus Xiao'er jiebiao oral liquid and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to 31 May 2018
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:subjects should meet all of the following
- diagnosed as hand-foot-mouth disease grade I or grade II;
- body temperature at admission T>38℃，fever length<48 hours;
- no need for hormonotherapy or immunoglobulin therapy.
- signed written informed consent form
Exclusion Criteria:subjects should be excluded if meet any of the following
- with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients
This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.
- Conditions
- Handfoot-mouth Disease
- Being tested
- Ribavirin plus Xiao'er jiebiao oral liquid, Ribavirin
- Keywords
- Mild and Moderate Severe Patients With hand_foot-mouth Disease
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribavirin plus Xiao'er jiebiao oral liquidDrug
For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.
For moderate (Phase II) patients:
recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid）
RibavirinDrug
For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip.
For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid）
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin treatment plus testing drug | Experimental | Not described Receives: Drug: Ribavirin plus Xiao'er jiebiao oral liquid |
| Ribavirin treatment | Active comparator | Not described Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (hours) taken from treatment start till body temperature dropping to normal
Measured: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
Time (hours) taken from disease onset till body temperature dropping to normal
Measured: time length (hours) from the disease onset (the starting of fever) till the time that body temperature dropped to normal (37.0 degree) and lasting for at least 12 hours
Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
top body temperature at 3 time points after treatment diarrhea
Measured: from starting of treatment to the 24th hour, 48th hour, and the 72th hour
Secondary outcomes (3)
adverse digestive tract symptoms
proportion of patients with digestive tract symptoms during treatment, such as vomit, abdomial pain or diarrhea
Measured: from start of treatment to discharge
abnormal blood routine
defined as 1 if any abnormal blood routine occur, otherwise defined as 0
Measured: from the start of treatment to discharge test
abnormal Urine routine
defined as 1 if any liver function examination or kidney function examination occur, otherwise defined as 0
Measured: from the start of treatment to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startOct 2014
- Primary completion30 Apr 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handfoot-mouth DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Weihai Rensheng Pharmacy
- Responsible party
- Principal investigator, Hui Yu, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328651
- Sponsor's protocol ID
- XEJB_Ver1.0
- Status last verified
- Aug 2018
- First submitted
- 18 Dec 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02328651
- Acronym / sponsor ID
- XEJB_Ver1.0
- Conditions
- Handfoot-mouth Disease
- Keywords
- Mild and Moderate Severe Patients With hand_foot-mouth Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Weihai Rensheng Pharmacy
- Study start
- Oct 2014
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 31 Dec 2014 (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.
This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribavirin treatment plus testing drug | Experimental | Drug: Ribavirin plus Xiao'er jiebiao oral liquid |
| Ribavirin treatment | Active comparator | Drug: Ribavirin |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Ribavirin plus Xiao'er jiebiao oral liquidFor mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years. For moderate (Phase II) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid） | Drug | Ribavirin treatment plus testing drug |
| RibavirinFor mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip. For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid） | Drug | Ribavirin treatment |
Primary outcome
Time (hours) taken from treatment start till body temperature dropping to normal
Time frame: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours
Time (hours) taken from disease onset till body temperature dropping to normal
Time frame: time length (hours) from the disease onset (the starting of fever) till the time that body temperature dropped to normal (37.0 degree) and lasting for at least 12 hours
Top body temperature at the 24th hour, 48th hour and the 72th hour from treatment starting.
Time frame: from starting of treatment to the 24th hour, 48th hour, and the 72th hour
top body temperature at 3 time points after treatment diarrhea
3 secondary outcomes
adverse digestive tract symptoms
Time frame: from start of treatment to discharge
abnormal blood routine
Time frame: from the start of treatment to discharge test
abnormal Urine routine
Time frame: from the start of treatment to discharge
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 7 Aug 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ribavirin plus Xiao'er jiebiao oral liquid and Ribavirin in people with Handfoot-mouth Disease, run by Children's Hospital of Fudan University 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?
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 7 Aug 2018. 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?
Time (hours) taken from treatment start till body temperature dropping to normal (time frame: time length( hours) from treatment starting to the time that body temperature drop to normal 37.0 degree for 12 hours). The study lists 3 primary outcomes in all. 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 7 Aug 2018.