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

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).

Study Overview

• Status: Completed
• Conditions: Hand, Foot, and Mouth Disease
• Intervention / Treatment: Drug: Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge); Drug: Xiyanping injection plus western therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Collaborators: Beijing YouAn Hospital; China Academy of Chinese Medical Sciences; Beijing University of Chinese Medicine; The First Affiliated Hospital of Anhui University of Traditional 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

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: March 11, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (ESTIMATE): March 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; HFMD; Xiyanping
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Hand, Foot and Mouth Disease; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Methylprednisolone; Mannitol; Immunoglobulins
• Other Study ID Numbers: 200907001-3