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

Hand, Foot and Mouth Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01182025
• Other study ID #: 200907001-4
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2010
• Last updated: August 16, 2010
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2010
• Source: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• 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; More than 1/3 patients should be diagnosed by etiological examination.

• Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes.

• Age of 1-14 years.

• Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

• Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.

• With history of allergies on traditional Chinese medicine.

• Patients or their guardians suffering from Psychiatric diseases.

• Attending other clinical studies on HFMD after diagnosed.

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

Other:
• Western therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 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.
• Xiyanping Injection with western medicine
Symptomatic treatment using the same treatment methods in western therapy group; Symptomatic treatment using the same treatment methods in Xiyanpin injection group.

Locations

Country	Name	City	State
China	Affiliated Hospital of Guilin Medical College	Guilin	Guangxi
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Jiangxi Provincial Children's Hospital	Nanchang	Jiangxi
China	Shenzhen Maternity & Child Healthcare Hospital	Shenzhen	Guangzhou

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of bringing down the fever	Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.	10 days	No
Primary	time of body temperature going back to normal	Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.	10 days	No
Secondary	time of symptom disappearance	Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.	10 days	No
Secondary	case severity rate	Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.	10 days	No
Secondary	time of tetter disappearance	Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.	10 days	No
Secondary	direct medical cost	Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.	10 days	No
Secondary	safety outcome	Calculated by adverse event.	10 days	Yes