A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

Not Applicable

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Drug: Western therapy; Drug: Herbal concentrate-granules plus western therapy; Drug: Reduning Injection plus western therapy

• Registration Number: NCT01145664
• Lead Sponsor: Beijing YouAn Hospital

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Last Update Submitted: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Posted: 2010-06-17
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by China's Ministry of Health
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Western therapy	Western therapy	-
Herbal concentrate-granules plus western therapy	Herbal concentrate-granules plus western therapy	-
Reduning Injection plus western therapy	Reduning Injection plus western therapy	-

Primary Outcome Measures

Name	Time	Method
incidence of complications	15 days
incidence of critically ill patients	15 days

Secondary Outcome Measures

Name	Time	Method
case fatality rate	15 days
time of symptom disappearance	15 days
time of bringing down a fever	15 days
length of stay	15 days
dose and usage of hormones	15 days
safety outcome(adverse effects)	15 days

Trial Locations

Locations (6)

Guangzhou Women and Children Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Kaifeng Municipal Children's Hospital; 🇨🇳 Kaifeng, Henan, China

Hunan Provincial Children's Hospital; 🇨🇳 Changsha, Hunan, China

Anhui Provincial Children's Hospital; 🇨🇳 Anhui, China

Beijing YouAn Hospital，Capital Medical University; 🇨🇳 Beijing, China