A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
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ClinicalTrials.gov Identifier: NCT01145664 |
Recruitment Status : Unknown
Verified May 2010 by Beijing YouAn Hospital.
Recruitment status was: Recruiting
First Posted : June 17, 2010
Last Update Posted : June 17, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hand, Foot and Mouth Disease | Drug: Herbal concentrate-granules plus western therapy Drug: Reduning Injection plus western therapy Drug: Western therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Western therapy |
Drug: Western therapy
Intervention time: 7-10 days; Follow-up time: 5 days. |
Experimental: Herbal concentrate-granules plus western therapy |
Drug: Herbal concentrate-granules plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days. |
Experimental: Reduning Injection plus western therapy |
Drug: Reduning Injection plus western therapy
Intervention time: 7-10 days; Follow-up time: 5 days. |
- incidence of complications [ Time Frame: 15 days ]
- incidence of critically ill patients [ Time Frame: 15 days ]
- 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 ]

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Ages Eligible for Study: | 1 Year to 13 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145664
China, Guangdong | |
Guangzhou Women and Children Hospital | Recruiting |
Guangzhou, Guangdong, China | |
Contact: Yi Xu 13416427315 | |
Sub-Investigator: Yi Xu | |
China, Guangxi | |
The First Affiliated Hospital of Guangxi Medical University | Recruiting |
Nanning, Guangxi, China | |
Contact: Dan Wei 13977166581 | |
Sub-Investigator: Dan Wei | |
China, Henan | |
Kaifeng Municipal Children's Hospital | Recruiting |
Kaifeng, Henan, China | |
Contact: Xi Zhang 13069307700 | |
Sub-Investigator: Xi Zhang | |
China, Hunan | |
Hunan Provincial Children's Hospital | Recruiting |
Changsha, Hunan, China | |
Contact: Shuangjie Li 15874162057 | |
Sub-Investigator: Shuangjie Li | |
China | |
Anhui Provincial Children's Hospital | Recruiting |
Anhui, China | |
Contact: Biquan Chen 13856065978 | |
Sub-Investigator: Biquan Chen | |
Beijing YouAn Hospital,Capital Medical University | Recruiting |
Beijing, China | |
Contact: Xiuhui li, MD 86-10-93997040 lixiuhui@sohu.com | |
Principal Investigator: Xiuhui Li, MD |
Responsible Party: | Xiuhui Li, Beijing YouAn Hospital,Capital Medical University |
ClinicalTrials.gov Identifier: | NCT01145664 |
Obsolete Identifiers: | NCT01314794 |
Other Study ID Numbers: |
200907001-3 |
First Posted: | June 17, 2010 Key Record Dates |
Last Update Posted: | June 17, 2010 |
Last Verified: | May 2010 |
Chinese medicines Severe hand-foot-mouth diseases effectiveness safety |
Foot-and-Mouth Disease Hand, Foot and Mouth Disease Mouth Diseases Stomatognathic Diseases Picornaviridae Infections |
RNA Virus Infections Virus Diseases Coxsackievirus Infections Enterovirus Infections |