NCT01769794

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

January 15, 2013

Last Update Submit

January 16, 2013

Conditions

Hand, Foot and Mouth Disease

Keywords

Hand, Foot and Mouth DiseaseMedicine, Chinese TraditionalEnterovirusFever

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Secondary Outcomes (4)

  • Healing time of skin or oral mucosa lesions symptom

    10 days

  • Score of skin or oral mucosa lesions symptom during the study period time

    10 days

  • the length of hospital stay

    10 days

  • major complications rate

    10 days

Study Arms (2)

Western therapy & Placebo

ACTIVE COMPARATOR

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

Drug: Western therapyDrug: Placebo(for JET)

Western therapy & JET

EXPERIMENTAL

Jinlianqingre Effervescent Tablets plus western therapy

Drug: Western therapyDrug: JET

Interventions

Western therapyDRUG

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

Western therapy & JETWestern therapy & Placebo
JETDRUG

4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)

Also known as: Jinlianqingre Effervescent Tablets
Western therapy & JET
Placebo(for JET)DRUG

placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)

Western therapy & Placebo

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tangshan infectious disease hospital

Tangshan, Hebei, 063020, China

Location

Affiliated Hospital of Chengdu university of Traditional Chinese Medicine

Chengdu, Sichuan, 610072, China

Location

Beijing children's hospital

Beijing, 100045, China

Location

Tianjin infectious disease hospital

Tianjin, 300192, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth DiseaseEnterovirus InfectionsFever

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

CN(4)