An interventional study of Western therapy and Reduning Injection in Hand, Foot and Mouth Disease, sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd. Status unknown at 6 sites in China. Open to participants aged 1 Year to 13 Years. Per ClinicalTrials.gov, last updated 2010-08-05.
Sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.
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.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 11 are open to participants now.
This study's planned enrollment of 360 is below the median of 445 across 50 interventional studies indexed under Hand, Foot and Mouth Disease.
Browse Hand, Foot and Mouth Disease studies →Jiangsu Kanion Pharmaceutical Co., Ltd is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Other: Western therapy
Other: Reduning Injection
Other: Reduning Injection plus 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.
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.
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.
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.
Time frame: 10 days
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.
Time frame: 10 days
time of symptom disappearance
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
Time frame: 10 days
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.
Time frame: 10 days
dose and usage of medicine
Refering to the dose and frequency of using the medicine.
Time frame: 10 days
case severity rate
Refering to the ratio of patient with mild type of HFMD to severe type.
Time frame: 10 days
adverse reaction incidence
Calculated by adverse event.
Time frame: 10 days
This study is status unknown, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Hand, Foot and Mouth Disease →
Jiangsu Kanion Pharmaceutical Co., Ltd