A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
1 other identifier
interventional
3,000
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
21 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
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 23, 2012
July 1, 2012
1.4 years
August 16, 2010
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
time to onset
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
10 days
time of body temperature going back to normal
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.
10 days
Secondary Outcomes (5)
time of symptom disappearance
10 days
case severity rate
10 days
time of tetter and oral ulcer disappearance
10 days
direct medical cost
10 days
safety outcome
10 days
Study Arms (3)
Western therapy
ACTIVE COMPARATORTCM treatment
EXPERIMENTALWestern therapy plus TCM treatment
EXPERIMENTALThe combination of both western therapy and TCM treatment.
Interventions
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 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;
1. Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint. Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction. 2. Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint. Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction.
1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Syndrome differentiation and treatment adopting the same methods in TCM treatment group.
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; 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
Hefei, Anhui, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing You-An Hospital
Beijing, Beijing Municipality, China
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
First Hospital of Lanzhou University
Lanzhou, Gausu, China
Shenzhen Third People's Hospital
Shenzhen, Guangzhou, China
The Fifth Hospital of Shijiazhuang, Hebei
Shijiazhuang, Hebei, China
Wuhan Hospital for Infectious Diseases
Wuhan, Hubei, China
Huhehaote Second Hospital
Hohhot, Inner Mongolia, China
Ninth Hospital of Nanchang
Nanchang, Jiangxi, China
Changchun Infectious Diseases Hospital
Changchun, Jilin, China
Ningxia Hui Autonomous Region Forth People's Hospital
Yinchuan, Ningxia Hui Autonomous, China
The Eighth Hospital of Xi'an City
Xi'an, Shaanxi, China
Shanghai Public Health Center
Shanghai, Shanghai Municipality, China
Chengdu Hospital for Infectious Diseases
Chengdu, Sichuan, China
Xinjiang Hongxing Hospital
Urumuqi, Xinjiang, China
First Affiliated Hospital to Kunming Medical College
Kunming, Yunnan, China
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoliang Zhang
An'Hui Chinese Medical College Affiliated No.1 Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 17, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
July 23, 2012
Record last verified: 2012-07