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A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborators:
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
Information provided by:
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01182025
First received: August 13, 2010
Last updated: August 16, 2010
Last verified: August 2010
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Purpose
The aim of this study is to evaluate the effectiveness and safety of Xiyanping Injection for mild type of hand, foot, and mouth disease.
| Condition | Intervention |
|---|---|
| Hand, Foot and Mouth Disease | Other: Western therapy Drug: Xiyanping Injection Drug: Xiyanping Injection with western medicine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:
Primary Outcome Measures:
- time of bringing down the fever [ 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.
Secondary Outcome Measures:
- time of symptom disappearance [ Time Frame: 10 days ]Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
- case severity rate [ Time Frame: 10 days ]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.
- time of tetter disappearance [ Time Frame: 10 days ]Refering to the length of time when the tetter due to HFMD disappears, characterised by scab(s) or dropping; and time of oral ulcer concrescence, etc.
- direct medical cost [ Time Frame: 10 days ]Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
- safety outcome [ Time Frame: 10 days ]Calculated by adverse event.
| Estimated Enrollment: | 360 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Western therapy |
Other: Western therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
|
| Experimental: Xiyanping Injection |
Drug: Xiyanping Injection
Dosage for child medication: 5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor. |
| Experimental: Xiyanping Injection with western medicine |
Drug: Xiyanping Injection with western medicine
|
Detailed Description:
By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Xiyanping Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and designed to combine both observational and interventional methodologies in this research.
Eligibility| Ages Eligible for Study: | 1 Year to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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; 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182025
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182025
Locations
| China, Guangxi | |
| Affiliated Hospital of Guilin Medical College | Recruiting |
| Guilin, Guangxi, China, 541001 | |
| Contact: Xiong Li 13737728526 yuanyanhui_888@163.com | |
| Principal Investigator: Xiong Li | |
| Liuzhou Worker's Hospital | Recruiting |
| Liuzhou, Guangxi, China, 541001 | |
| Contact: Liuping Tang 18977228768 yongren126zeng@126.com | |
| Contact: Zhe Guo 13978009767 sdy761212@163.com | |
| Principal Investigator: Liuping Tang | |
| Principal Investigator: Zhe Guo | |
| Liuzhou People's Hospital | Recruiting |
| Liuzhou, Guangxi, China, 545001 | |
| Contact: Tong Yang 13977286628 zhoubing-1995@163.com | |
| Principal Investigator: Tong Yang | |
| China, Guangzhou | |
| Shenzhen Maternity & Child Healthcare Hospital | Recruiting |
| Shenzhen, Guangzhou, China, 518028 | |
| Contact: Xinying Zou 13129559135 Xuzhiymr@yahoo.com.cn | |
| Principal Investigator: Xinying Zou | |
| China, Jiangxi | |
| Jiangxi Provincial Children's Hospital | Recruiting |
| Nanchang, Jiangxi, China, 330006 | |
| Contact: Qingxiong Zhu 15979003000 Zhuqingxiong2000@163.com | |
| Principal Investigator: Qingxiong Zhu | |
Sponsors and Collaborators
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Beijing University of Chinese Medicine
China Academy of Chinese Medical Sciences
Investigators
| Principal Investigator: | Guoliang Zhang | An'Hui Chinese Medical College Affiliated No.1 Hospital |
More Information
| Responsible Party: | Guoliang Zhang, The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01182025 History of Changes |
| Other Study ID Numbers: |
200907001-4 |
| Study First Received: | August 13, 2010 |
| Last Updated: | August 16, 2010 |
Keywords provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:
|
Mild type of hand, foot and mouth disease Xiyanping Injection Effectiveness Safety |
Additional relevant MeSH terms:
|
Mouth Diseases Foot-and-Mouth Disease Hand, Foot and Mouth Disease Stomatognathic Diseases Picornaviridae Infections |
RNA Virus Infections Virus Diseases Coxsackievirus Infections Enterovirus Infections |
ClinicalTrials.gov processed this record on July 21, 2017