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| Name | Class |
|---|---|
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Beijing Children's Hospital | OTHER |
| Tianjin infectious disease hospital | UNKNOWN |
| Tangshan infectious disease hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western therapy & Placebo | Active Comparator | Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets ) |
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| Western therapy & JET | Experimental | Jinlianqingre Effervescent Tablets plus western therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Western therapy | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Score of skin or oral mucosa lesions symptom during the study period time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boyan Liu, chief physician | China Academy of Chinese Medical Sciences | Study Chair |
| Guoliang Zhang, chief | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangshan infectious disease hospital | Tangshan | Hebei | 063020 | China | ||
| Affiliated Hospital of Chengdu university of Traditional Chinese Medicine |
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| UNKNOWN |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd. | UNKNOWN |
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|
| JET | Drug | 4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃) |
|
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| Placebo(for JET) | Drug | placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China) |
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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). |
| 10 days |
| the length of hospital stay | 10 days |
| major complications rate | Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al. | 10 days |
| Chengdu |
| Sichuan |
| 610072 |
| China |
| Beijing children's hospital | Beijing | 100045 | China |
| Tianjin infectious disease hospital | Tianjin | 300192 | China |
| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| D004769 | Enterovirus Infections |
| D005334 | Fever |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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