A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
NCT ID: NCT01175915
Last Updated: 2010-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2010-05-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Western therapy
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.
Reduning Injection
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.
Reduning Injection plus western therapy
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
13 Years
ALL
No
Sponsors
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Beijing University of Chinese Medicine
OTHER
Jiangsu Kanion Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Jiangsu Kanion Pharmaceutical Co.,Ltd
Principal Investigators
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Wei Xiao
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Kanion Pharmaceutical Co., Ltd
Locations
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An'Hui Provincial Children's Hospital
Hefei, An'Hui, China
Fujian Provincial Quanzhou City Children's Hospital
Quanzhou, Fujian, China
The Fifth Hospital of Shijiazhuang City
Shijiazhuang, Hebei, China
Kaifeng Municipal Children's Hospital
Kaifeng, Henan, China
Hunan Provincial Children's Hospital
Changsha, Hunan, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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200907001-3-1
Identifier Type: -
Identifier Source: org_study_id
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