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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• dose and usage of medicine [ Time Frame: 10 days ]
  Refering to the dose and frequency of using the medicine.
• case severity rate [ Time Frame: 10 days ]
  Refering to the ratio of patient with mild type of HFMD to severe type.
• adverse reaction incidence [ Time Frame: 10 days ]
  Calculated by adverse event.

Original Secondary Outcome: Same as current

Information By: Jiangsu Kanion Pharmaceutical Co., Ltd

Dates:
Date Received: August 4, 2010
Date Started: May 2010
Date Completion: August 2010
Last Updated: August 4, 2010
Last Verified: August 2010