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

NCT ID: NCT01769794

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-10-31

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.

Conditions

Hand, Foot and Mouth Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Western therapy & Placebo

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

Group Type: ACTIVE_COMPARATOR

Western therapy

Intervention Type: DRUG

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

Placebo(for JET)

Intervention Type: DRUG

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

Western therapy & JET

Jinlianqingre Effervescent Tablets plus western therapy

Group Type: EXPERIMENTAL

Western therapy

Intervention Type: DRUG

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

JET

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

JET

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

Intervention Type: DRUG

Placebo(for JET)

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

Intervention Type: DRUG

Other Intervention Names

Jinlianqingre Effervescent Tablets

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Tianjin infectious disease hospital

UNKNOWN

Sponsor Role: collaborator

Tangshan infectious disease hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liyun He

chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boyan Liu, chief physician

Role: STUDY_CHAIR

China Academy of Chinese Medical Sciences

Guoliang Zhang, chief

Role: STUDY_CHAIR

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Locations

Tangshan infectious disease hospital

Tangshan, Hebei, China

Affiliated Hospital of Chengdu university of Traditional Chinese Medicine

Chengdu, Sichuan, China

Beijing children's hospital

Beijing, , China

Tianjin infectious disease hospital

Tianjin, , China

Countries

China

Other Identifiers

ChinaACMS-HFMD

Identifier Type: -

Identifier Source: org_study_id