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

Hand, Foot, and Mouth Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554930
• Other study ID #: 200907001-3
• Status: Completed
• Phase: N/A
• First received: March 11, 2012
• Last updated: March 14, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Hand, Foot, and Mouth Disease
• Mouth Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Handan Maternal and Child Health Care Hospital	Handan	Hebei
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Jiangxi Children's Hospital	Nanchang	Jiangxi

Sponsors (5)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.	Beijing University of Chinese Medicine, Beijing YouAn Hospital, China Academy of Chinese Medical Sciences, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	time of symptom disappearance	Referring to the length of time when clinical symptoms and signs totally disappear after the medicine is used.	15 days	No
Secondary	safety outcome	Calculated by adverse event	15 days	Yes