Clinical trial NCT01182532: A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand, Foot and Mouth Disease
Keywords: Mild type of hand, foot and mouth disease
Traditional Chinese Medicine
Effectiveness
Safety
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
name: China Academy of Chinese Medical Sciences
First posted: 2010-08-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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.

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 traditional Chinese medicine.
* Patients or their guardians suffering from Psychiatric diseases.
* Attending other clinical studies on HFMD after diagnosed.

Primary outcomes:
measure: time to onset
timeFrame: 10 days
measure: time of body temperature going back to normal
timeFrame: 10 days
Secondary outcomes:
measure: time of symptom disappearance
timeFrame: 10 days
measure: case severity rate
timeFrame: 10 days
measure: time of tetter and oral ulcer disappearance
timeFrame: 10 days
measure: direct medical cost
timeFrame: 10 days
measure: safety outcome
timeFrame: 10 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing You-An Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Hospital of Traditional Chinese Medicine
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou Infectious Disease Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
state: Fujian
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University
state: Gausu
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangzhou
city: Shijiazhuang
country: China
facility: The Fifth Hospital of Shijiazhuang, Hebei
state: Hebei
city: Wuhan
country: China
facility: Wuhan Hospital for Infectious Diseases
state: Hubei
city: Huhehaote
country: China
facility: Huhehaote Second Hospital
state: Inner Mongolia
city: Nanchang
country: China
facility: Ninth Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: Changchun Infectious Diseases Hospital
state: Jilin
city: Yinchuan
country: China
facility: Ningxia Hui Autonomous Region Forth People's Hospital
state: Ningxia Hui Autonomous
city: Xi'an
country: China
facility: The Eighth Hospital of Xi'an City
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Public Health Center
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Hospital for Infectious Diseases
state: Sichuan
city: Urumuqi
country: China
facility: Xinjiang Hongxing Hospital
state: Xinjiang
city: Kunming
country: China
facility: First Affiliated Hospital to Kunming Medical College
state: Yunnan
city: Hangzhou
country: China
facility: The Sixth People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: An'Hui Chinese Medical College Affiliated No.1 Hospital
name: Guoliang Zhang
role: PRINCIPAL_INVESTIGATOR
References: