Hand, Foot and Mouth DiseaseNCT01769794
Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
A study testing Western therapy and JET in people with Hand, Foot and Mouth Disease, run by China Academy of Chinese Medical Sciences at 4 sites in China.
Trial summary
The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD). 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?
- Western therapy and JET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2011to Oct 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
- Within 48 hours of onset of fever and rash symptom.
- Age of 1-13 years.
- Documented body temperature 37.4 °C-39.0°C
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Who cannot join
- Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
- With history of allergies on traditional Chinese medicine.
- Attending other clinical studies on HFMD after diagnosed.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing children's hospital
Beijing, 100045
Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
Tangshan infectious disease hospital
Tangshan, Hebei, 063020
Tianjin infectious disease hospital
Tianjin, 300192
About this study
The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).
Read the detailed description
By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated 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, JET, Placebo(for JET)
- Keywords
- Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Enterovirus, Fever
- Medical subject headings
- Hand, Foot and Mouth Disease, Enterovirus Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western therapyDrug
Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form
JETDrug
Also called Jinlianqingre Effervescent Tablets
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
Placebo(for JET)Drug
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
| Study group | Role | What they receive |
|---|---|---|
| Western therapy & Placebo | Active comparator | Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets ) Receives: Drug: Western therapy; Drug: Placebo(for JET) |
| Western therapy & JET | Experimental | Jinlianqingre Effervescent Tablets plus western therapy Receives: Drug: Western therapy; Drug: JET |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of body temperature going back to normal
Referring 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 (4)
Healing time of skin or oral mucosa lesions symptom
Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.
Measured: 10 days
Score of skin or oral mucosa lesions symptom during the study period time
Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe).
Measured: 10 days
the length of hospital stay
Measured: 10 days
major complications rate
Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.
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 Jan 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine, Beijing Children's Hospital, Tianjin infectious disease hospital, Tangshan infectious disease hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
- Responsible party
- Principal investigator, Liyun He, China Academy of Chinese Medical Sciences
- Investigators
- Boyan Liu, chief physician, Study chair, China Academy of Chinese Medical SciencesGuoliang Zhang, chief, Study chair, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769794
- Sponsor's protocol ID
- ChinaACMS-HFMD
- Status last verified
- Jan 2013
- First submitted
- 15 Jan 2013
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01769794
- Acronym / sponsor ID
- ChinaACMS-HFMD
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Enterovirus, Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine, Beijing Children's Hospital, Tianjin infectious disease hospital, Tangshan infectious disease hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Jan 2013 (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 Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).
Detailed description
By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Western therapy & Placebo | Active comparator | Drug: Western therapy, Drug: Placebo(for JET)Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets ) |
| Western therapy & JET | Experimental | Drug: Western therapy, Drug: JETJinlianqingre Effervescent Tablets plus western therapy |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
- Within 48 hours of onset of fever and rash symptom.
- Age of 1-13 years.
- Documented body temperature 37.4 °C-39.0°C
- Patients or their guardians agree to participate in this study and signed the informed consent form.
Key exclusion criteria (3 listed)
- Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
- With history of allergies on traditional Chinese medicine.
- 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 therapyPhysical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form | Drug | Western therapy & JET, Western therapy & Placebo |
| JETAlso: Jinlianqingre Effervescent Tablets4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃) | Drug | Western therapy & JET |
| Placebo(for JET)placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China) | Drug | Western therapy & Placebo |
Primary outcome
The time of body temperature going back to normal
Time frame: 10 days
Referring 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.
4 secondary outcomes
Healing time of skin or oral mucosa lesions symptom
Time frame: 10 days
Score of skin or oral mucosa lesions symptom during the study period time
Time frame: 10 days
the length of hospital stay
Time frame: 10 days
major complications rate
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 17 Jan 2013.
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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.
Boyan Liu, chief physician study chair
China Academy of Chinese Medical Sciences
Guoliang Zhang, chief study chair
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
4 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 and JET in people with Hand, Foot and Mouth Disease, run by China Academy of Chinese Medical Sciences at 4 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 5 inclusion and 3 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 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The time of body temperature going back to normal (time frame: 10 days). 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 17 Jan 2013.