Hand, Foot and Mouth DiseaseNCT01182025
A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
A study testing Western therapy, Xiyanping Injection and Xiyanping Injection with western medicine in people with Hand, Foot and Mouth Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 5 sites in China.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- Western therapy, Xiyanping Injection and Xiyanping Injection with western medicine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesChina
- Study dates
- Jun 2010to Dec 2011
- Phase
- Interventional
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
- Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
- Age of 1-14 years.
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Who cannot join
- Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
- With history of allergies on traditional Chinese medicine.
- Patients or their guardians suffering from Psychiatric diseases.
- Attending other clinical studies on HFMD after diagnosed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, 541001
Xiong Li, 13737728526, yuanyanhui_888@163.com
Xiong Li
- Recruiting
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 541001
Liuping Tang, 18977228768, yongren126zeng@126.com
Zhe Guo, 13978009767, sdy761212@163.com
- Recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545001
Tong Yang, 13977286628, zhoubing-1995@163.com
Tong Yang
- Recruiting
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006
Qingxiong Zhu, 15979003000, Zhuqingxiong2000@163.com
Qingxiong Zhu
- Recruiting
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangzhou, 518028
Xinying Zou, 13129559135, Xuzhiymr@yahoo.com.cn
Xinying Zou
About this study
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
Read the detailed description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- Western therapy, Xiyanping Injection, Xiyanping Injection with western medicine
- Keywords
- Mild type of hand, foot and mouth disease, Xiyanping Injection, Effectiveness, Safety
- Medical subject headings
- Hand, Foot and Mouth Disease, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western therapyOther
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
- Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
- Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;
Xiyanping InjectionDrug
Dosage for child medication:
5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor.
Xiyanping Injection with western medicineDrug
- Symptomatic treatment using the same treatment methods in western therapy group;
- Symptomatic treatment using the same treatment methods in Xiyanpin injection group.
| Study group | Role | What they receive |
|---|---|---|
| Western therapy | Active comparator | Not described Receives: Other: Western therapy |
| Xiyanping Injection | Experimental | Not described Receives: Drug: Xiyanping Injection |
| Xiyanping Injection with western medicine | Experimental | Not described Receives: Drug: Xiyanping Injection with western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of bringing down the fever
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
Measured: 10 days
time of body temperature going back to normal
Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.
Measured: 10 days
Secondary outcomes (5)
time of symptom disappearance
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
Measured: 10 days
case severity rate
Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
Measured: 10 days
time of tetter disappearance
Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.
Measured: 10 days
direct medical cost
Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
Measured: 10 days
safety outcome
Calculated by adverse event.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
- Investigators
- Guoliang Zhang, Principal investigator, An'Hui Chinese Medical College Affiliated No.1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182025
- Sponsor's protocol ID
- 200907001-4
- Status last verified
- Aug 2010
- First submitted
- 13 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
- ClinicalTrials.gov ID
- NCT01182025
- Acronym / sponsor ID
- 200907001-4
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Mild type of hand, foot and mouth disease, Xiyanping Injection, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
- Study start
- Jun 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Aug 2010 (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.
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
Detailed description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western therapy | Active comparator | Other: Western therapy |
| Xiyanping Injection | Experimental | Drug: Xiyanping Injection |
| Xiyanping Injection with western medicine | Experimental | Drug: Xiyanping Injection with western medicine |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
- Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.
- Age of 1-14 years.
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Key exclusion criteria (4 listed)
- Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
- With history of allergies on traditional Chinese medicine.
- Patients or their guardians suffering from Psychiatric diseases.
- Attending other clinical studies on HFMD after diagnosed.
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 |
|---|---|---|
| Western therapySymptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius; | Other | Western therapy |
| Xiyanping InjectionDosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor. | Drug | Xiyanping Injection |
| Xiyanping Injection with western medicine1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Symptomatic treatment using the same treatment methods in Xiyanpin injection group. | Drug | Xiyanping Injection with western medicine |
Primary outcome
time of bringing down the fever
Time frame: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal
Time frame: 10 days
Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.
5 secondary outcomes
time of symptom disappearance
Time frame: 10 days
case severity rate
Time frame: 10 days
time of tetter disappearance
Time frame: 10 days
direct medical cost
Time frame: 10 days
safety outcome
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
Related trials for Hand, Foot and Mouth Disease
Not yet recruiting
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
Hand, Foot and Mouth Disease, Infection Control
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Not yet recruitingPhase 1
Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
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.
Guoliang Zhang principal investigator
An'Hui Chinese Medical College Affiliated No.1 Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western therapy, Xiyanping Injection and Xiyanping Injection with western medicine in people with Hand, Foot and Mouth Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 5 sites 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 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of bringing down the fever (time frame: 10 days). The study lists 2 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 17 Aug 2010.