Hand, Foot and Mouth DiseaseNCT01145664
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
A study testing Herbal concentrate-granules plus western therapy, Reduning Injection plus western therapy and Western therapy in people with Hand, Foot and Mouth Disease, run by Beijing YouAn Hospital at 6 sites in China.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- Herbal concentrate-granules plus western therapy, Reduning Injection plus western therapy and Western therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 6 sitesChina
- Study dates
- May 2010to Aug 2010
- 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 13 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
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Anhui Provincial Children's Hospital
Anhui
Biquan Chen, 13856065978
Biquan Chen
- Recruiting
Beijing YouAn Hospital，Capital Medical University
Beijing
Xiuhui li, MD, 86-10-93997040, lixiuhui@sohu.com
Xiuhui Li, MD
- Recruiting
Hunan Provincial Children's Hospital
Changsha, Hunan
Shuangjie Li, 15874162057
Shuangjie Li
- Recruiting
Guangzhou Women and Children Hospital
Guangzhou, Guangdong
Yi Xu, 13416427315
Yi Xu
- Recruiting
Kaifeng Municipal Children's Hospital
Kaifeng, Henan
Xi Zhang, 13069307700
Xi Zhang
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Dan Wei, 13977166581
Dan Wei
About this study
The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- Herbal concentrate-granules plus western therapy, Reduning Injection plus western therapy, Western therapy
- Keywords
- Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal concentrate-granules plus western therapyDrug
Intervention time: 7-10 days; Follow-up time: 5 days.
Reduning Injection plus western therapyDrug
Intervention time: 7-10 days; Follow-up time: 5 days.
Western therapyDrug
Intervention time: 7-10 days; Follow-up time: 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Western therapy | Active comparator | Not described Receives: Drug: Western therapy |
| Herbal concentrate-granules plus western therapy | Experimental | Not described Receives: Drug: Herbal concentrate-granules plus western therapy |
| Reduning Injection plus western therapy | Experimental | Not described Receives: Drug: Reduning Injection plus western therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of complications
Measured: 15 days
incidence of critically ill patients
Measured: 15 days
Secondary outcomes (6)
case fatality rate
Measured: 15 days
time of symptom disappearance
Measured: 15 days
time of bringing down a fever
Measured: 15 days
length of stay
Measured: 15 days
dose and usage of hormones
Measured: 15 days
safety outcome(adverse effects)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing YouAn Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145664
- Sponsor's protocol ID
- 200907001-3
- Status last verified
- May 2010
- First submitted
- 16 Jun 2010
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27392481
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
- ClinicalTrials.gov ID
- NCT01145664
- Acronym / sponsor ID
- 200907001-3
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Beijing YouAn HospitalUniversity, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China, China Academy of Chinese Medical Sciences, Beijing University of Chinese Medicine
- Study start
- May 2010
- Primary completion
- Aug 2010 (estimated)
- First posted
- 17 Jun 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 aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
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 | Drug: Western therapy |
| Herbal concentrate-granules plus western therapy | Experimental | Drug: Herbal concentrate-granules plus western therapy |
| Reduning Injection plus western therapy | Experimental | Drug: Reduning Injection plus western therapy |
Who may qualify
- Ages
- 1 year to 13 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
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Herbal concentrate-granules plus western therapyIntervention time: 7-10 days; Follow-up time: 5 days. | Drug | Herbal concentrate-granules plus western therapy |
| Reduning Injection plus western therapyIntervention time: 7-10 days; Follow-up time: 5 days. | Drug | Reduning Injection plus western therapy |
| Western therapyIntervention time: 7-10 days; Follow-up time: 5 days. | Drug | Western therapy |
Primary outcome
incidence of complications
Time frame: 15 days
incidence of critically ill patients
Time frame: 15 days
6 secondary outcomes
case fatality rate
Time frame: 15 days
time of symptom disappearance
Time frame: 15 days
time of bringing down a fever
Time frame: 15 days
length of stay
Time frame: 15 days
dose and usage of hormones
Time frame: 15 days
safety outcome(adverse effects)
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2010.
- Derived from this study: PubMed 27392481Li 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.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal concentrate-granules plus western therapy, Reduning Injection plus western therapy and Western therapy in people with Hand, Foot and Mouth Disease, run by Beijing YouAn Hospital at 6 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 7 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: status not confirmed, as of the sponsor's last update on 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications (time frame: 15 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?
On the ClinicalTrials.gov record for NCT01145664, which also lists 1 linked publication.
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 17 Jun 2010.