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

August 4, 2010
August 4, 2010
May 2010
August 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hand, Foot and Mouth Disease
  • 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.

  • 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.

  • 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.

  • Active Comparator: Western therapy
    Intervention: Other: Western therapy
  • Experimental: Reduning Injection
    Intervention: Other: Reduning Injection
  • Experimental: Reduning Injection plus western therapy
    Intervention: Other: Reduning Injection plus western therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
1 Year to 13 Years
No
Not Provided
China
 
NCT01175915
200907001-3-1
Yes
Wei Xiao, Jiangsu Kanion Pharmaceutical Co.,Ltd
Jiangsu Kanion Pharmaceutical Co.,Ltd
Beijing University of Chinese Medicine
Principal Investigator: Wei Xiao Jiangsu Kanion Pharmaceutical Co.,Ltd
Jiangsu Kanion Pharmaceutical Co.,Ltd
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP