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

August 4, 2010 updated by: Jiangsu Kanion Pharmaceutical Co., Ltd
The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • An'Hui Provincial Children's Hospital
        • Contact:
        • Principal Investigator:
          • Biquan Chen
    • Fujian
      • Quanzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Quanzhou City Children's Hospital
        • Contact:
        • Principal Investigator:
          • Zhiqiang Zhuo
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fifth Hospital of Shijiazhuang City
        • Contact:
        • Principal Investigator:
          • Haojie Zheng
    • Henan
      • Kaifeng, Henan, China
        • Recruiting
        • Kaifeng Municipal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Xi Zhang
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial Children's Hospital
        • Contact:
        • Principal Investigator:
          • Shuangjie Li
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
        • Principal Investigator:
          • Yongping Mu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of body temperature going back to normal
Time Frame: 10 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.
10 days
time of bringing down the fever
Time Frame: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of symptom disappearance
Time Frame: 10 days
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
10 days
time of tetter disappearance
Time Frame: 10 days
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.
10 days
dose and usage of medicine
Time Frame: 10 days
Refering to the dose and frequency of using the medicine.
10 days
case severity rate
Time Frame: 10 days
Refering to the ratio of patient with mild type of HFMD to severe type.
10 days
adverse reaction incidence
Time Frame: 10 days
Calculated by adverse event.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Kanion Pharmaceutical Co., Ltd

Collaborators

Beijing University of Chinese Medicine

Investigators

  • Principal Investigator: Wei Xiao, Jiangsu Kanion Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2010

Study Completion (ANTICIPATED)

August 1, 2010

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (ESTIMATE)

August 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2010

Last Update Submitted That Met QC Criteria

August 4, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200907001-3-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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