NCT01175915

A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 1 Year – 13 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.

Detailed 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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
OTHER	Western therapy	1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius lasting for more than 2 hours; 3. 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.
OTHER	Reduning Injection	1. Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics; 2. Reduning Injection, 0.5\~15ml, depending on patient's condition, IV per day, or according to the instruction; 3. 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.
OTHER	Reduning Injection plus western therapy	1. General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows; 2. Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group; 3. Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group. Intervention time: 3-7 days; Follow-up time: 3 days.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-08-05
• Last updated: 2010-08-05

Locations

6 sites across 1 country: China