Clinical trial NCT01145664: A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand, Foot and Mouth Disease
Keywords: Chinese medicines
Severe hand-foot-mouth diseases
effectiveness
safety
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
Collaborators: name: State Administration of Traditional Chinese Medicine of the People's Republic of China
name: China Academy of Chinese Medical Sciences
name: Beijing University of Chinese Medicine
First posted: 2010-06-17
Enrollment: 390
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.


Eligibility criteria: Inclusion Criteria:

1. 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
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness

Primary outcomes:
measure: incidence of complications
timeFrame: 15 days
measure: incidence of critically ill patients
timeFrame: 15 days
Secondary outcomes:
measure: case fatality rate
timeFrame: 15 days
measure: time of symptom disappearance
timeFrame: 15 days
measure: time of bringing down a fever
timeFrame: 15 days
measure: length of stay
timeFrame: 15 days
measure: dose and usage of hormones
timeFrame: 15 days
measure: safety outcome(adverse effects)
timeFrame: 15 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Kaifeng
country: China
facility: Kaifeng Municipal Children's Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Provincial Children's Hospital
state: Hunan
city: Anhui
country: China
facility: Anhui Provincial Children's Hospital
city: Beijing
country: China
facility: Beijing YouAn Hospital，Capital Medical University
Study officials:
References:
citation: Li XH, Li SJ, Xu Y, Wei D, Shi QS, Zhu QX, Yang T, Ding JB, Tian YM, Huang JH, Wang K, Wen T, Zhang X. Effect of integrated Chinese and Western medicine therapy on severe hand, foot and mouth disease: A prospective, randomized, controlled trial. Chin J Integr Med. 2017 Dec;23(12):887-892. doi: 10.1007/s11655-016-2504-3. Epub 2016 Jul 9.