Clinical Trial: A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping 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 Xiyanping Injection for mild type of hand, foot, and mouth disease.

Detailed Summary: By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

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.
• case severity rate [ Time Frame: 10 days ]
  Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
• 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.
• direct medical cost [ Time Frame: 10 days ]
  Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
• safety outcome [ Time Frame: 10 days ]
  Calculated by adverse event.

Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Dates:
Date Received: August 13, 2010
Date Started: June 2010
Date Completion: December 2011
Last Updated: August 16, 2010
Last Verified: August 2010