search
Back to results

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

Primary Purpose

Hand, Foot and Mouth Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Herbal concentrate-granules plus western therapy
Reduning Injection plus western therapy
Western therapy
Sponsored by
Beijing YouAn Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand, Foot and Mouth Disease focused on measuring Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety

Eligibility Criteria

1 Year - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou Women and Children HospitalRecruiting
  • The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
  • Kaifeng Municipal Children's HospitalRecruiting
  • Hunan Provincial Children's HospitalRecruiting
  • Anhui Provincial Children's HospitalRecruiting
  • Beijing YouAn Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Western therapy

Herbal concentrate-granules plus western therapy

Reduning Injection plus western therapy

Arm Description

Outcomes

Primary Outcome Measures

incidence of complications
incidence of critically ill patients

Secondary Outcome Measures

case fatality rate
time of symptom disappearance
time of bringing down a fever
length of stay
dose and usage of hormones
safety outcome(adverse effects)

Full Information

First Posted
June 16, 2010
Last Updated
June 16, 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
search

1. Study Identification

Unique Protocol Identification Number
NCT01145664
Brief Title
A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
Chinese medicines, Severe hand-foot-mouth diseases, effectiveness, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Western therapy
Arm Type
Active Comparator
Arm Title
Herbal concentrate-granules plus western therapy
Arm Type
Experimental
Arm Title
Reduning Injection plus western therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Herbal concentrate-granules plus western therapy
Intervention Description
Intervention time: 7-10 days; Follow-up time: 5 days.
Intervention Type
Drug
Intervention Name(s)
Reduning Injection plus western therapy
Intervention Description
Intervention time: 7-10 days; Follow-up time: 5 days.
Intervention Type
Drug
Intervention Name(s)
Western therapy
Intervention Description
Intervention time: 7-10 days; Follow-up time: 5 days.
Primary Outcome Measure Information:
Title
incidence of complications
Time Frame
15 days
Title
incidence of critically ill patients
Time Frame
15 days
Secondary Outcome Measure Information:
Title
case fatality rate
Time Frame
15 days
Title
time of symptom disappearance
Time Frame
15 days
Title
time of bringing down a fever
Time Frame
15 days
Title
length of stay
Time Frame
15 days
Title
dose and usage of hormones
Time Frame
15 days
Title
safety outcome(adverse effects)
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Guangzhou Women and Children Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Xu
Phone
13416427315
First Name & Middle Initial & Last Name & Degree
Yi Xu
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Wei
Phone
13977166581
First Name & Middle Initial & Last Name & Degree
Dan Wei
Facility Name
Kaifeng Municipal Children's Hospital
City
Kaifeng
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Zhang
Phone
13069307700
First Name & Middle Initial & Last Name & Degree
Xi Zhang
Facility Name
Hunan Provincial Children's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangjie Li
Phone
15874162057
First Name & Middle Initial & Last Name & Degree
Shuangjie Li
Facility Name
Anhui Provincial Children's Hospital
City
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biquan Chen
Phone
13856065978
First Name & Middle Initial & Last Name & Degree
Biquan Chen
Facility Name
Beijing YouAn Hospital，Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhui li, MD
Phone
86-10-93997040
Email
lixiuhui@sohu.com
First Name & Middle Initial & Last Name & Degree
Xiuhui Li, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27392481
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs