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

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).

Conditions

• Hand, Foot and Mouth Disease

Interventions

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℃)

DRUG

Placebo(for JET)

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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Tianjin infectious disease hospital

  collaborator UNKNOWN

• Tangshan infectious disease hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

  collaborator OTHER

• Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.

  collaborator UNKNOWN

• China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Boyan Liu, chief physician · China Academy of Chinese Medical Sciences

• Guoliang Zhang, chief · The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2011-10-31

Completion

2011-10-31

Countries

• China

Study Locations