A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
- Conditions
- Hand, Foot and Mouth Disease
- Interventions
- Other: Western therapyDrug: TCM Syndrome Differentiation and TreatmentOther: Western therapy plus TCM treatment
- Registration Number
- NCT01182532
- Lead Sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Brief Summary
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
- Detailed Description
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Western therapy Western therapy - TCM treatment TCM Syndrome Differentiation and Treatment - Western therapy plus TCM treatment Western therapy plus TCM treatment The combination of both western therapy and TCM treatment.
- Primary Outcome Measures
Name Time Method time to onset 10 days Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal 10 days 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.
- Secondary Outcome Measures
Name Time Method time of symptom disappearance 10 days Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
case severity rate 10 days 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.
time of tetter and oral ulcer disappearance 10 days Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, etc.
direct medical cost 10 days Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
safety outcome 10 days Calculated by adverse event.
Trial Locations
- Locations (21)
Ninth Hospital of Nanchang
π¨π³Nanchang, Jiangxi, China
Anhui Provincial Children's Hospital
π¨π³Hefei, Anhui, China
Xiamen Hospital of Traditional Chinese Medicine
π¨π³Xiamen, Fujian, China
Changchun Infectious Diseases Hospital
π¨π³Changchun, Jilin, China
Fuzhou Infectious Disease Hospital
π¨π³Fuzhou, Fujian, China
Chengdu Hospital for Infectious Diseases
π¨π³Chengdu, Sichuan, China
Beijing Ditan Hospital
π¨π³Beijing, Beijing, China
The Eighth Hospital of Xi'an City
π¨π³Xi'an, Shaanxi, China
Xinjiang Hongxing Hospital
π¨π³Urumuqi, Xinjiang, China
Ningxia Hui Autonomous Region Forth People's Hospital
π¨π³Yinchuan, Ningxia Hui Autonomous, China
The Sixth People's Hospital of Hangzhou
π¨π³Hangzhou, Zhejiang, China
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
π¨π³Hefei, Anhui, China
Beijing You-An Hospital
π¨π³Beijing, Beijing, China
Chongqing Hospital of Traditional Chinese Medicine
π¨π³Chongqing, Chongqing, China
First Hospital of Lanzhou University
π¨π³Lanzhou, Gausu, China
Huhehaote Second Hospital
π¨π³Huhehaote, Inner Mongolia, China
Wuhan Hospital for Infectious Diseases
π¨π³Wuhan, Hubei, China
Shenzhen Third People's Hospital
π¨π³Shenzhen, Guangzhou, China
The Fifth Hospital of Shijiazhuang, Hebei
π¨π³Shijiazhuang, Hebei, China
First Affiliated Hospital to Kunming Medical College
π¨π³Kunming, Yunnan, China
Shanghai Public Health Center
π¨π³Shanghai, Shanghai, China