A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
1 other identifier
interventional
390
1 country
6
Brief Summary
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedJune 17, 2010
May 1, 2010
3 months
June 16, 2010
June 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
incidence of complications
15 days
incidence of critically ill patients
15 days
Secondary Outcomes (6)
case fatality rate
15 days
time of symptom disappearance
15 days
time of bringing down a fever
15 days
length of stay
15 days
dose and usage of hormones
15 days
- +1 more secondary outcomes
Study Arms (3)
Western therapy
ACTIVE COMPARATORHerbal concentrate-granules plus western therapy
EXPERIMENTALReduning Injection plus western therapy
EXPERIMENTALInterventions
Intervention time: 7-10 days; Follow-up time: 5 days.
Intervention time: 7-10 days; Follow-up time: 5 days.
Eligibility Criteria
You may qualify if:
- 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
- not more than 24 hours of occurrence of severe symptoms
- age of 1-13 years
- Patients or their guardians agree to participate in this study and signed the informed consent form
You may not qualify if:
- Suffering from neurogenic pulmonary edema, heart or lung failure.
- Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
- the history of allergies on Chinese medicine
- the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
- using hormonal therapy
- Attending other clinical studies on hand-foot-mouth disease
- Patients or their guardians suffering from mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Guangzhou Women and Children Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Kaifeng Municipal Children's Hospital
Kaifeng, Henan, China
Hunan Provincial Children's Hospital
Changsha, Hunan, China
Anhui Provincial Children's Hospital
Anhui, China
Beijing YouAn Hospital，Capital Medical University
Beijing, China
Related Publications (1)
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.
PMID: 27392481DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 17, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2010
Last Updated
June 17, 2010
Record last verified: 2010-05