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

This study has been completed.
Sponsor:
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.
Information provided by (Responsible Party):
Liyun He, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01769794
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Hand, Foot and Mouth Disease
Drug: Western therapy
Drug: JET
Drug: Placebo(for JET)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • The time of body temperature going back to normal [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • major complications rate [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.


Enrollment: 288
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Western therapy & Placebo
Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
Drug: Western therapy
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
Drug: Placebo(for JET)
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
Experimental: Western therapy & JET
Jinlianqingre Effervescent Tablets plus western therapy
Drug: Western therapy
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
Drug: JET
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
Other Name: Jinlianqingre Effervescent Tablets

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.

  Eligibility

Ages Eligible for Study:   1 Year to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01769794

Locations
China, Hebei
Tangshan infectious disease hospital
Tangshan, Hebei, China, 063020
China, Sichuan
Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072
China
Beijing children's hospital
Beijing, China, 100045
Tianjin infectious disease hospital
Tianjin, China, 300192
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
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.
Investigators
Study Chair: Boyan Liu, chief physician China Academy of Chinese Medical Sciences
Study Chair: Guoliang Zhang, chief The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Liyun He, chief, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01769794     History of Changes
Other Study ID Numbers: ChinaACMS-HFMD
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by China Academy of Chinese Medical Sciences:
Hand, Foot and Mouth Disease
Medicine, Chinese Traditional
Enterovirus
Fever

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014