A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
NCT ID: NCT01182532
Last Updated: 2012-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3000 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Western therapy
Western therapy
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;
TCM treatment
TCM Syndrome Differentiation and Treatment
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.
Western therapy plus TCM treatment
The combination of both western therapy and TCM treatment.
Western therapy plus TCM treatment
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.
Interventions
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Western therapy
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;
TCM Syndrome Differentiation and Treatment
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.
Western therapy plus TCM treatment
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
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Inclusion Criteria
* 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
* With history of allergies on traditional Chinese medicine.
* Patients or their guardians suffering from Psychiatric diseases.
* Attending other clinical studies on HFMD after diagnosed.
1 Year
14 Years
ALL
No
Sponsors
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Beijing University of Chinese Medicine
OTHER
China Academy of Chinese Medical Sciences
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Responsible Party
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Guoliang Zhang
Chief
Principal Investigators
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Guoliang Zhang
Role: PRINCIPAL_INVESTIGATOR
An'Hui Chinese Medical College Affiliated No.1 Hospital
Locations
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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
Countries
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Other Identifiers
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200907001-3
Identifier Type: -
Identifier Source: org_study_id