Status:

UNKNOWN

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

Lead Sponsor:

Jiangsu Kanion Pharmaceutical Co., Ltd

Collaborating Sponsors:

Beijing University of Chinese Medicine

Conditions:

Hand, Foot and Mouth Disease

Eligibility:

All Genders

1-13 years

Phase:

NA

Brief Summary

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

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, ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2010

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT01175915

Start Date

May 1 2010

End Date

August 1 2010

Last Update

August 5 2010

Active Locations (6)

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Page 1 of 2 (6 locations)

1

An'Hui Provincial Children's Hospital

Hefei, An'Hui, China

2

Fujian Provincial Quanzhou City Children's Hospital

Quanzhou, Fujian, China

3

The Fifth Hospital of Shijiazhuang City

Shijiazhuang, Hebei, China

4

Kaifeng Municipal Children's Hospital

Kaifeng, Henan, China