Hand, Foot, and Mouth DiseaseNCT01554930

Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

A study testing Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) and Xiyanping injection plus western therapy in people with Hand, Foot, and Mouth Disease, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD). Read more about this study

Who is it for?: Ages 1 year to 13 years
Conditions the study is for: Hand, Foot, and Mouth Disease
What is being tested?: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) and Xiyanping injection plus western therapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 3 sitesChina
Study dates: May 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 13 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 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
Age of 1-13 years.
Patients or their guardians agree to participate in this study and signed the informed consent form.

Who cannot join

Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
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 who using glucocorticoids for based diseases.
Patients who having history of hemolysis.
Patients or their guardians suffering from Psychiatric diseases.
Attending other clinical studies on HFMD after diagnosed.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Handan Maternal and Child Health Care Hospital
Handan, Hebei
Liuzhou People's Hospital
Liuzhou, Guangxi
Jiangxi Children's Hospital
Nanchang, Jiangxi

Other trials in China

About this study

Official title: A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

Read the detailed description

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Conditions: Hand, Foot, and Mouth Disease
Being tested: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge), Xiyanping injection plus western therapy
Keywords: HFMD, Traditional Chinese Medicine, Xiyanping
Medical subject headings: Hand, Foot and Mouth Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)Drug
Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Xiyanping injection plus western therapyDrug
Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

Study groups in NCT01554930
Study group	Role	What they receive
Western therapy	Active comparator	Not described Receives: Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Xiyanping injection plus western therapy	Experimental	Not described Receives: Drug: Xiyanping injection plus western therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

complication rate
Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.
Measured: 15 days

Secondary outcomes (3)

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: 15 days
time of symptom disappearance
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
Measured: 15 days
safety outcome
Calculated by adverse event
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2011

First posted15 Mar 2012 (estimated)
Study startMay 2010
Primary completionNov 2010
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
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: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01554930
Sponsor's protocol ID: 200907001-3
Status last verified: Mar 2012
First submitted: 11 Mar 2012
Last updated: 15 Mar 2012
Results posted: No
Data monitoring committee: Yes

Publications

Hamaguchi T, Fujisawa H, Sakai K, Okino S, Kurosaki N, Nishimura Y, Shimizu H, Yamada M. Acute encephalitis caused by intrafamilial transmission of enterovirus 71 in adult. Emerg Infect Dis. 2008 May;14(5):828-30. doi: 10.3201/eid1405.071121.
PubMed 18439374
Hosoya M, Kawasaki Y, Sato M, Honzumi K, Hayashi A, Hiroshima T, Ishiko H, Kato K, Suzuki H. Genetic diversity of coxsackievirus A16 associated with hand, foot, and mouth disease epidemics in Japan from 1983 to 2003. J Clin Microbiol. 2007 Jan;45(1):112-20. doi: 10.1128/JCM.00718-06. Epub 2006 Nov 8.
PubMed 17093028
Yoke-Fun C, AbuBakar S. Phylogenetic evidence for inter-typic recombination in the emergence of human enterovirus 71 subgenotypes. BMC Microbiol. 2006 Aug 30;6:74. doi: 10.1186/1471-2180-6-74.
PubMed 16939656
Chang LY, King CC, Hsu KH, Ning HC, Tsao KC, Li CC, Huang YC, Shih SR, Chiou ST, Chen PY, Chang HJ, Lin TY. Risk factors of enterovirus 71 infection and associated hand, foot, and mouth disease/herpangina in children during an epidemic in Taiwan. Pediatrics. 2002 Jun;109(6):e88. doi: 10.1542/peds.109.6.e88.
PubMed 12042582
Shen WC, Chiu HH, Chow KC, Tsai CH. MR imaging findings of enteroviral encephaloymelitis: an outbreak in Taiwan. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1889-95.
PubMed 10588115

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Hand, Foot, and Mouth Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2012. 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 Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease
ClinicalTrials.gov ID: NCT01554930
Acronym / sponsor ID: 200907001-3
Conditions: Hand, Foot, and Mouth Disease
Keywords: HFMD, Traditional Chinese Medicine, Xiyanping
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Collaborators: China Academy of Chinese Medical Sciences, Beijing YouAn Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Beijing University of Chinese Medicine
Study start: May 2010
Primary completion: Nov 2010 (actual)
Study completion: Dec 2011 (actual)
First posted: 15 Mar 2012 (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 study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Western therapy	Active comparator	Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)
Xiyanping injection plus western therapy	Experimental	Drug: Xiyanping injection plus western therapy

Who may qualify

Ages: 1 year to 13 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 24 hours of occurrence of fever and/or occurrence of tetter or herpes.
Age of 1-13 years.
Patients or their guardians agree to participate in this study and signed the informed consent form.

Key exclusion criteria (7 listed)

Complicated with other diseases such as neurogenic pulmonary edema, cardiopulmonary failure.
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 who using glucocorticoids for based diseases.
Patients who having history of hemolysis.

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 therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.	Drug	Western therapy
Xiyanping injection plus western therapyXiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.	Drug	Xiyanping injection plus western therapy

Primary outcome

complication rate
Time frame: 15 days
Refering to the ratio of patient having complications such as pulmonary edema, myocarditis，damage of central nervous system，shock, respiratory failure, multiple organ failur etc.

3 secondary outcomes

time of body temperature going back to normal
Time frame: 15 days
time of symptom disappearance
Time frame: 15 days
safety outcome
Time frame: 15 days

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 15 Mar 2012.
Background: PubMed 18439374Hamaguchi T, Fujisawa H, Sakai K, Okino S, Kurosaki N, Nishimura Y, Shimizu H, Yamada M. Acute encephalitis caused by intrafamilial transmission of enterovirus 71 in adult. Emerg Infect Dis. 2008 May;14(5):828-30. doi: 10.3201/eid1405.071121.
Background: PubMed 17093028Hosoya M, Kawasaki Y, Sato M, Honzumi K, Hayashi A, Hiroshima T, Ishiko H, Kato K, Suzuki H. Genetic diversity of coxsackievirus A16 associated with hand, foot, and mouth disease epidemics in Japan from 1983 to 2003. J Clin Microbiol. 2007 Jan;45(1):112-20. doi: 10.1128/JCM.00718-06. Epub 2006 Nov 8.
Background: PubMed 16939656Yoke-Fun C, AbuBakar S. Phylogenetic evidence for inter-typic recombination in the emergence of human enterovirus 71 subgenotypes. BMC Microbiol. 2006 Aug 30;6:74. doi: 10.1186/1471-2180-6-74.
Background: PubMed 12042582Chang LY, King CC, Hsu KH, Ning HC, Tsao KC, Li CC, Huang YC, Shih SR, Chiou ST, Chen PY, Chang HJ, Lin TY. Risk factors of enterovirus 71 infection and associated hand, foot, and mouth disease/herpangina in children during an epidemic in Taiwan. Pediatrics. 2002 Jun;109(6):e88. doi: 10.1542/peds.109.6.e88.
Background: PubMed 10588115Shen WC, Chiu HH, Chow KC, Tsai CH. MR imaging findings of enteroviral encephaloymelitis: an outbreak in Taiwan. AJNR Am J Neuroradiol. 1999 Nov-Dec;20(10):1889-95.

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.

Li Xiu hui, PhD study chair

Beijing You-An Hospital

Zhang Guo liang, PhD study chair

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Shi Qin sheng, PhD principal investigator

Handan Maternal and Child Health Care Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

complication rate (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01554930, which also lists 5 linked publications.

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 15 Mar 2012.