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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Mouth Diseases
Hand, Foot and Mouth Disease
Stomatognathic Diseases
Coxsackievirus Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunoglobulins
Antibodies
Mannitol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 16, 2014