MedTrace Logo

A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

NCT01175915 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2010-08-05

No results posted yet for this study

Summary

The aim of this study is to evaluate the effectiveness and safety of Reduning Injection for mild type of hand-foot-mouth disease.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

OTHER

Western therapy

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 lasting for more than 2 hours; 3. No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes. Intervention time: 3-7 days; Follow-up time: 3 days.

OTHER

Reduning Injection

1. Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics; 2. Reduning Injection, 0.5\~15ml, depending on patient's condition, IV per day, or according to the instruction; 3. Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours. Intervention time: 3-7 days; Follow-up time: 3 days.

OTHER

Reduning Injection plus western therapy

1. General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows; 2. Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group; 3. Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group. Intervention time: 3-7 days; Follow-up time: 3 days.

Sponsors & Collaborators

  • Beijing University of Chinese Medicine

    collaborator OTHER

  • Jiangsu Kanion Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Wei Xiao · Jiangsu Kanion Pharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01175915 on ClinicalTrials.gov