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A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Jiangsu Kanion Pharmaceutical Co.,Ltd.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by:
Jiangsu Kanion Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01175915
First received: August 4, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.


Condition Intervention
Hand, Foot and Mouth Disease
 Other: Western therapy
Other: Reduning Injection
Other: Reduning Injection plus western therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jiangsu Kanion Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • time of bringing down the fever [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

  • time of body temperature going back to normal [ Time Frame: 10 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.


Secondary Outcome Measures:
  • time of symptom disappearance [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.

  • time of tetter disappearance [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.

  • dose and usage of medicine [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the dose and frequency of using the medicine.

  • case severity rate [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Refering to the ratio of patient with mild type of HFMD to severe type.

  • adverse reaction incidence [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Calculated by adverse event.


Estimated Enrollment: 360
Study Start Date: May 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Western therapy Other: Western therapy
  1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
  2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius lasting for more than 2 hours;
  3. No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes.

Intervention time: 3-7 days; Follow-up time: 3 days.
Experimental: Reduning Injection Other: Reduning Injection
  1. Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics;
  2. Reduning Injection, 0.5~15ml, depending on patient's condition, IV per day, or according to the instruction;
  3. Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours.

Intervention time: 3-7 days; Follow-up time: 3 days.
Experimental: Reduning Injection plus western therapy Other: Reduning Injection plus western therapy
  1. General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows;
  2. Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group;
  3. Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group.

Intervention time: 3-7 days; Follow-up time: 3 days.

Detailed Description:

By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

  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 48 hours of occurrence of mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius.
  • Less than 48 hours of 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 serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
  • With history of allergies on the experimental medicine, or severe allergies to other medicines.
  • Using other western medicine or Chinese medicine for treating HFMD when consulted.
  • Attending other clinical studies on HFMD after diagnosed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175915

Locations
China, Anhui
An'Hui Provincial Children's Hospital Recruiting
Hefei, Anhui, China
Contact: Biquan Chen     13856065978     anhuicbq4049@sina.com    
Principal Investigator: Biquan Chen            
China, Fujian
Fujian Provincial Quanzhou City Children's Hospital Recruiting
Quanzhou, Fujian, China
Contact: Zhiqiang Zhuo     13905984912     zzq2191190@tom.com    
Principal Investigator: Zhiqiang Zhuo            
China, Hebei
The Fifth Hospital of Shijiazhuang City Recruiting
Shijiazhuang, Hebei, China
Contact: Haojie Zheng     13933872363     zhj76711@yahoo.com.cn    
Principal Investigator: Haojie Zheng            
China, Henan
Kaifeng Municipal Children's Hospital Recruiting
Kaifeng, Henan, China
Contact: Xi Zhang     13069307700     kfzhangxi@sohu.com    
Principal Investigator: Xi Zhang            
China, Hunan
Hunan Provincial Children's Hospital Recruiting
Changsha, Hunan, China
Contact: Shuangjie Li     15874162057     lesjie62@sohu.com    
Principal Investigator: Shuangjie Li            
China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China
Contact: Yongping Mu     13818869248     ypmu8888@126.com    
Principal Investigator: Yongping Mu            
Sponsors and Collaborators
Jiangsu Kanion Pharmaceutical Co.,Ltd
Beijing University of Chinese Medicine
Investigators
Principal Investigator: Wei Xiao Jiangsu Kanion Pharmaceutical Co.,Ltd
  More Information

No publications provided

Responsible Party: Wei Xiao, Jiangsu Kanion Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01175915     History of Changes
Other Study ID Numbers: 200907001-3-1
Study First Received: August 4, 2010
Last Updated: August 4, 2010
Health Authority: China: Ethics Committee

Keywords provided by Jiangsu Kanion Pharmaceutical Co.,Ltd:
Mild type of hand, foot and mouth disease
Reduning Injection
Effectiveness
Safety

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 22, 2013