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

This study has been completed.

Sponsor:

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

Information provided by (Responsible Party):

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

ClinicalTrials.gov Identifier:

NCT01554930

First received: March 11, 2012

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Purpose

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).

Condition	Intervention
Hand, Foot, and Mouth Disease	Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge) Drug: Xiyanping injection plus western therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Mouth Disorders

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Mannitol Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

U.S. FDA Resources

Further study details as provided by Jiangxi Qingfeng Pharmaceutical Co. Ltd.:

Primary Outcome Measures:

complication rate [ Time Frame: 15 days ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

time of body temperature going back to normal [ Time Frame: 15 days ] [ Designated as safety issue: No ]
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.
time of symptom disappearance [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
safety outcome [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Calculated by adverse event

Enrollment:	230
Study Start Date:	May 2010
Study Completion Date:	December 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Western therapy	Drug: 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.
Experimental: Xiyanping injection plus western therapy	Drug: Xiyanping injection plus western therapy 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.

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.

Eligibility

Ages Eligible for Study:	1 Year to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554930

Locations

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

Sponsors and Collaborators

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Investigators

Study Chair:	Li Xiu hui, PhD	Beijing You-An Hospital
Study Chair:	Zhang Guo liang, PhD	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Principal Investigator:	Shi Qin sheng, PhD	Handan Maternal and Child Health Care Hospital
Principal Investigator:	Zhu Qin xiong, PhD	Jiangxi Children's Hospital
Principal Investigator:	Yang tong, PhD	Liuzhou People's Hospital

More Information

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.

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. Epub 2006 Nov 8.

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.

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.

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.

Responsible Party:	Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier:	NCT01554930 History of Changes
Other Study ID Numbers:	200907001-3
Study First Received:	March 11, 2012
Last Updated:	March 14, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Jiangxi Qingfeng Pharmaceutical Co. Ltd.:

HFMD
Traditional Chinese Medicine
Xiyanping

Additional relevant MeSH terms:

Hand, Foot and Mouth Disease
Mouth Diseases
Coxsackievirus Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Stomatognathic Diseases
Immunoglobulins
Antibodies
Mannitol
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate

Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013

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