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

Overview

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).

Full Title of Study: “A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Western therapy
  • Experimental: Xiyanping injection plus western therapy

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • time of body temperature going back to normal
    • Time Frame: 15 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.
  • time of symptom disappearance
    • Time Frame: 15 days
    • Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.
  • safety outcome
    • Time Frame: 15 days
    • Calculated by adverse event

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangxi Qingfeng Pharmaceutical Co. Ltd.
  • Collaborator
    • China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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
    • Zhu Qin xiong, PhD, Principal Investigator, Jiangxi Children’s Hospital
    • Yang tong, PhD, Principal Investigator, LiuZhou People’s Hospital

References

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. 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.

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