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

Hand, Foot and Mouth Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01145664
• Other study ID #: 200907001-3
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2010
• Last updated: June 16, 2010
• Start date: May 2010

Study information

• Verified date: May 2010
• Source: Beijing YouAn Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing YouAn Hospital's IRB
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01314794

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Drug:
• Herbal concentrate-granules plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
• Reduning Injection plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.
• Western therapy
Intervention time: 7-10 days; Follow-up time: 5 days.

Locations

Country	Name	City	State
China	Anhui Provincial Children's Hospital	Anhui
China	Beijing YouAn Hospital,Capital Medical University	Beijing
China	Hunan Provincial Children's Hospital	Changsha	Hunan
China	Guangzhou Women and Children Hospital	Guangzhou	Guangdong
China	Kaifeng Municipal Children's Hospital	Kaifeng	Henan
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (4)

Lead Sponsor	Collaborator
Beijing YouAn Hospital	Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, State Administration of Traditional Chinese Medicine of the People's Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of complications		15 days	No
Primary	incidence of critically ill patients		15 days	No
Secondary	case fatality rate		15 days	No
Secondary	time of symptom disappearance		15 days	No
Secondary	time of bringing down a fever		15 days	No
Secondary	length of stay		15 days	No
Secondary	dose and usage of hormones		15 days	No
Secondary	safety outcome(adverse effects)		15 days	Yes