search
Back to results

Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Western therapy
JET
Placebo(for JET)
Sponsored by
China Academy of Chinese Medical Sciences
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 Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Enterovirus, Fever

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
  • Within 48 hours of onset of fever and rash symptom.
  • Age of 1-13 years.
  • Documented body temperature 37.4 °C-39.0°C
  • Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

  • Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
  • With history of allergies on traditional Chinese medicine.
  • Attending other clinical studies on HFMD after diagnosed.

Sites / Locations

  • Tangshan infectious disease hospital
  • Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
  • Beijing children's hospital
  • Tianjin infectious disease hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Western therapy & Placebo

Western therapy & JET

Arm Description

Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )

Jinlianqingre Effervescent Tablets plus western therapy

Outcomes

Primary Outcome Measures

The time of body temperature going back to normal
Referring 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

Healing time of skin or oral mucosa lesions symptom
Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.
Score of skin or oral mucosa lesions symptom during the study period time
Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe).
the length of hospital stay
major complications rate
Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.

Full Information

First Posted
January 15, 2013
Last Updated
January 16, 2013
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Chengdu University of Traditional Chinese Medicine, Beijing Children's Hospital, Tianjin infectious disease hospital, Tangshan infectious disease hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01769794
Brief Title
Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Chengdu University of Traditional Chinese Medicine, Beijing Children's Hospital, Tianjin infectious disease hospital, Tangshan infectious disease hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).
Detailed Description
By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

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
Hand, Foot and Mouth Disease, Medicine, Chinese Traditional, Enterovirus, Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Western therapy & Placebo
Arm Type
Active Comparator
Arm Description
Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
Arm Title
Western therapy & JET
Arm Type
Experimental
Arm Description
Jinlianqingre Effervescent Tablets plus western therapy
Intervention Type
Drug
Intervention Name(s)
Western therapy
Intervention Description
Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form
Intervention Type
Drug
Intervention Name(s)
JET
Other Intervention Name(s)
Jinlianqingre Effervescent Tablets
Intervention Description
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
Intervention Type
Drug
Intervention Name(s)
Placebo(for JET)
Intervention Description
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
Primary Outcome Measure Information:
Title
The time of body temperature going back to normal
Description
Referring 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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Healing time of skin or oral mucosa lesions symptom
Description
Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.
Time Frame
10 days
Title
Score of skin or oral mucosa lesions symptom during the study period time
Description
Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe).
Time Frame
10 days
Title
the length of hospital stay
Time Frame
10 days
Title
major complications rate
Description
Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.
Time Frame
10 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 mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; Within 48 hours of onset of fever and rash symptom. Age of 1-13 years. Documented body temperature 37.4 °C-39.0°C Patients or their guardians agree to participate in this study and signed the informed consent form. Exclusion Criteria: Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases. With history of allergies on traditional Chinese medicine. Attending other clinical studies on HFMD after diagnosed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boyan Liu, chief physician
Organizational Affiliation
China Academy of Chinese Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guoliang Zhang, chief
Organizational Affiliation
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Tangshan infectious disease hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063020
Country
China
Facility Name
Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Beijing children's hospital
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Tianjin infectious disease hospital
City
Tianjin
ZIP/Postal Code
300192
Country
China

12. IPD Sharing Statement

Learn more about this trial

Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

We'll reach out to this number within 24 hrs