A Clinical Trial To Evaluate Reduning 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: NCT01175915
• Other study ID #: 200907001-3-1
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2010
• Last updated: August 4, 2010
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Jiangsu Kanion Pharmaceutical Co., Ltd
• 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 Reduning Injection for mild type of hand-foot-mouth disease.

Description:

By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 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 mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius.

• Less than 48 hours of occurrence of tetter or herpes.

• Age of 1-13 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 the experimental medicine, or severe allergies to other medicines.

• Using other western medicine or Chinese medicine for treating HFMD when consulted.

• Attending other clinical studies on HFMD after diagnosed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Other:
• Western therapy
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 lasting for more than 2 hours; No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes. Intervention time: 3-7 days; Follow-up time: 3 days.
• Reduning Injection
Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics; Reduning Injection, 0.5~15ml, depending on patient's condition, IV per day, or according to the instruction; Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours. Intervention time: 3-7 days; Follow-up time: 3 days.
• Reduning Injection plus western therapy
General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows; Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group; Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group. Intervention time: 3-7 days; Follow-up time: 3 days.

Locations

Country	Name	City	State
China	Hunan Provincial Children's Hospital	Changsha	Hunan
China	An'Hui Provincial Children's Hospital	Hefei	Anhui
China	Kaifeng Municipal Children's Hospital	Kaifeng	Henan
China	Fujian Provincial Quanzhou City Children's Hospital	Quanzhou	Fujian
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The Fifth Hospital of Shijiazhuang City	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Kanion Pharmaceutical Co., Ltd	Beijing University of Chinese Medicine

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	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	dose and usage of medicine	Refering to the dose and frequency of using the medicine.	10 days	No
Secondary	case severity rate	Refering to the ratio of patient with mild type of HFMD to severe type.	10 days	No
Secondary	adverse reaction incidence	Calculated by adverse event.	10 days	Yes