Hand, Foot and Mouth DiseaseNCT01182532
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
A study testing Western therapy, TCM Syndrome Differentiation and Treatment and Western therapy plus TCM treatment in people with Hand, Foot and Mouth Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 21 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- Western therapy, TCM Syndrome Differentiation and Treatment and Western therapy plus TCM treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 21 sitesChina
- Study dates
- May 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Beijing Ditan Hospital
Beijing, Beijing Municipality
Beijing You-An Hospital
Beijing, Beijing Municipality
Changchun Infectious Diseases Hospital
Changchun, Jilin
Chengdu Hospital for Infectious Diseases
Chengdu, Sichuan
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang
Anhui Provincial Children's Hospital
Hefei, Anhui
The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine
Hefei, Anhui
Huhehaote Second Hospital
Hohhot, Inner Mongolia
First Affiliated Hospital to Kunming Medical College
Kunming, Yunnan
First Hospital of Lanzhou University
Lanzhou, Gausu
Ninth Hospital of Nanchang
Nanchang, Jiangxi
Shanghai Public Health Center
Shanghai, Shanghai Municipality
Shenzhen Third People's Hospital
Shenzhen, Guangzhou
The Fifth Hospital of Shijiazhuang, Hebei
Shijiazhuang, Hebei
Xinjiang Hongxing Hospital
Urumuqi, Xinjiang
Wuhan Hospital for Infectious Diseases
Wuhan, Hubei
The Eighth Hospital of Xi'an City
Xi'an, Shaanxi
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian
Ningxia Hui Autonomous Region Forth People's Hospital
Yinchuan, Ningxia Hui Autonomous
About this study
The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).
Read the 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.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- Western therapy, TCM Syndrome Differentiation and Treatment, Western therapy plus TCM treatment
- Keywords
- Mild type of hand, foot and mouth disease, Traditional Chinese Medicine, Effectiveness, Safety
- Medical subject headings
- Hand, Foot and Mouth Disease, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western therapyOther
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
- Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
- Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;
TCM Syndrome Differentiation and TreatmentDrug
- 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.
- 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 treatmentOther
- Symptomatic treatment using the same treatment methods in western therapy group;
- Syndrome differentiation and treatment adopting the same methods in TCM treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Western therapy | Active comparator | Not described Receives: Other: Western therapy |
| TCM treatment | Experimental | Not described Receives: Drug: TCM Syndrome Differentiation and Treatment |
| Western therapy plus TCM treatment | Experimental | The combination of both western therapy and TCM treatment. Receives: Other: Western therapy plus TCM treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to onset
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
Measured: 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.
Measured: 10 days
Secondary outcomes (5)
time of symptom disappearance
Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
Measured: 10 days
case severity rate
Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
Measured: 10 days
time of tetter and oral ulcer disappearance
Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, etc.
Measured: 10 days
direct medical cost
Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
Measured: 10 days
safety outcome
Calculated by adverse event.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Guoliang Zhang, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Investigators
- Guoliang Zhang, Principal investigator, An'Hui Chinese Medical College Affiliated No.1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182532
- Sponsor's protocol ID
- 200907001-3
- Status last verified
- Jul 2012
- First submitted
- 16 Aug 2010
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
- ClinicalTrials.gov ID
- NCT01182532
- Acronym / sponsor ID
- 200907001-3
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Mild type of hand, foot and mouth disease, Traditional Chinese Medicine, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western therapy | Active comparator | Other: Western therapy |
| TCM treatment | Experimental | Drug: TCM Syndrome Differentiation and Treatment |
| Western therapy plus TCM treatment | Experimental | Other: Western therapy plus TCM treatmentThe combination of both western therapy and TCM treatment. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Western therapySymptomatic 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; | Other | Western therapy |
| TCM Syndrome Differentiation and Treatment1. 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. | Drug | TCM treatment |
| Western therapy plus TCM treatment1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Syndrome differentiation and treatment adopting the same methods in TCM treatment group. | Other | Western therapy plus TCM treatment |
Primary outcome
time to onset
Time frame: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal
Time frame: 10 days
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.
5 secondary outcomes
time of symptom disappearance
Time frame: 10 days
case severity rate
Time frame: 10 days
time of tetter and oral ulcer disappearance
Time frame: 10 days
direct medical cost
Time frame: 10 days
safety outcome
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoliang Zhang principal investigator
An'Hui Chinese Medical College Affiliated No.1 Hospital
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western therapy, TCM Syndrome Differentiation and Treatment and Western therapy plus TCM treatment in people with Hand, Foot and Mouth Disease, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to onset (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.