NCT01182025

A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
OTHER	Western therapy	Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 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;
DRUG	Xiyanping Injection	Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor.
DRUG	Xiyanping Injection with western medicine	1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Symptomatic treatment using the same treatment methods in Xiyanpin injection group.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2010-08-16
• Last updated: 2010-08-17

Locations

5 sites across 1 country: China