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

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).

Conditions

• Hand, Foot, and Mouth Disease

Interventions

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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

  collaborator OTHER

• Beijing University of Chinese Medicine

  collaborator OTHER

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.

  lead INDUSTRY

Principal Investigators

• Li Xiu hui, PhD · Beijing You-An Hospital

• Zhang Guo liang, PhD · The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

• Shi Qin sheng, PhD · Handan Maternal and Child Health Care Hospital

• Zhu Qin xiong, PhD · Jiangxi Children's Hospital

• Yang tong, PhD · LiuZhou People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2010-11-30

Completion

2011-12-31

Countries

• China

Study Locations