NCT01554930

Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease

A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Severe Type of Hand, Foot, and Mouth Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 1 Year – 13 Years
• Healthy volunteers: Not accepted

Summary

The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).

Detailed description

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine, Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Conditions

• Hand, Foot, and Mouth Disease

Interventions

Type	Name	Description
DRUG	Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)	Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
DRUG	Xiyanping injection plus western therapy	Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-11-01
• Completion: 2011-12-01
• First posted: 2012-03-15
• Last updated: 2012-03-15

Locations

3 sites across 1 country: China