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

The aim of this study is to evaluate the effectiveness and safety of Chinese herbal medicines for severe hand-foot-mouth disease.

Study Overview

• Status: Unknown
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Drug: Western therapy; Drug: Herbal concentrate-granules plus western therapy; Drug: Reduning Injection plus western therapy

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui, China
    • Recruiting
    • Anhui Provincial Children's Hospital
    • Contact: Biquan Chen; Phone Number: 13856065978
    • Sub-Investigator: Biquan Chen
  • Beijing, China
    • Recruiting
    • Beijing Youan Hospital,Capital Medical University
    • Principal Investigator: Xiuhui Li, MD
    • Contact: Xiuhui li, MD; Phone Number: 86-10-93997040; Email: lixiuhui@sohu.com
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou Women and Children Hospital
      • Contact: Yi Xu; Phone Number: 13416427315
      • Sub-Investigator: Yi Xu
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Dan Wei; Phone Number: 13977166581
      • Sub-Investigator: Dan Wei
  • Henan
    • Kaifeng, Henan, China
      • Recruiting
      • Kaifeng Municipal Children's Hospital
      • Contact: Xi Zhang; Phone Number: 13069307700
      • Sub-Investigator: Xi Zhang
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial Children's Hospital
      • Contact: Shuangjie Li; Phone Number: 15874162057
      • Sub-Investigator: Shuangjie Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of complications	15 days
incidence of critically ill patients	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
case fatality rate	15 days
time of symptom disappearance	15 days
time of bringing down a fever	15 days
length of stay	15 days
dose and usage of hormones	15 days
safety outcome(adverse effects)	15 days

Collaborators and Investigators

• Sponsor: Beijing YouAn Hospital
• Collaborators: China Academy of Chinese Medical Sciences; Beijing University of Chinese Medicine; State Administration of Traditional Chinese Medicine of the People's Republic of China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): June 17, 2010
• Last Update Submitted That Met QC Criteria: June 16, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: safety; effectiveness; Chinese medicines; Severe hand-foot-mouth diseases
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: 200907001-3