NCT01182532

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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).

Detailed description

By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2010-08-17
• Last updated: 2012-07-23

Locations

21 sites across 1 country: China