A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease

• ClinicalTrials.gov Identifier: NCT01145664
• Recruitment Status: Unknown
• First Posted: June 17, 2010
• Last Update Posted: June 17, 2010
• Sponsor: Beijing YouAn Hospital
• 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
• Information provided by: Beijing YouAn Hospital

Tracking Information

• First Submitted Date: June 16, 2010
• First Posted Date: June 17, 2010
• Last Update Posted Date: June 17, 2010
• Study Start Date: May 2010
• Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2010)

• incidence of complications [ Time Frame: 15 days ]
• incidence of critically ill patients [ Time Frame: 15 days ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 16, 2010)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
• Official Title: Not Provided
• Brief Summary: The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hand, Foot and Mouth Disease

Intervention

• Drug: Herbal concentrate-granules plus western therapy
  Intervention time: 7-10 days; Follow-up time: 5 days.
• Drug: Reduning Injection plus western therapy
  Intervention time: 7-10 days; Follow-up time: 5 days.
• Drug: Western therapy
  Intervention time: 7-10 days; Follow-up time: 5 days.

Study Arms

• Active Comparator: Western therapy
  Intervention: Drug: Western therapy
• Experimental: Herbal concentrate-granules plus western therapy
  Intervention: Drug: Herbal concentrate-granules plus western therapy
• Experimental: Reduning Injection plus western therapy
  Intervention: Drug: Reduning Injection plus western therapy

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 16, 2010): 390
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. 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
2. not more than 24 hours of occurrence of severe symptoms
3. age of 1-13 years
4. Patients or their guardians agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Suffering from neurogenic pulmonary edema, heart or lung failure.
2. Complicated with other serious diseases such as chronic hepatitis, congenital heart disease, acute or chronic nephritis and blood diseases, etc
3. the history of allergies on Chinese medicine
4. the history of mild increase of blood bilirubin hemolysis (or uric bravery former positive) phenomenon
5. using hormonal therapy
6. Attending other clinical studies on hand-foot-mouth disease
7. Patients or their guardians suffering from mental illness

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 13 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01145664
• Other Study ID Numbers: 200907001-3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xiuhui Li, Beijing YouAn Hospital，Capital Medical University
• Study Sponsor: Beijing YouAn Hospital

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

• Investigators: Not Provided
• PRS Account: Beijing YouAn Hospital
• Verification Date: May 2010