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A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

NCT01182532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2012-07-23

No results posted yet for this study

Summary

The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for treatment of hand, foot, and mouth disease (HFMD).

Conditions

  • Hand, Foot and Mouth Disease

Interventions

OTHER

Western therapy

Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. 1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; 2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;

DRUG

TCM Syndrome Differentiation and Treatment

1. Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint. Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction. 2. Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint. Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction.

OTHER

Western therapy plus TCM treatment

1. Symptomatic treatment using the same treatment methods in western therapy group; 2. Syndrome differentiation and treatment adopting the same methods in TCM treatment group.

Sponsors & Collaborators

  • Beijing University of Chinese Medicine

    collaborator OTHER

  • China Academy of Chinese Medical Sciences

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Guoliang Zhang · An'Hui Chinese Medical College Affiliated No.1 Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01182532 on ClinicalTrials.gov