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

NCT ID: NCT01175915

Last Updated: 2010-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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By adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of Reduning Injection in the treatment of mild type of Hand, Foot and Mouth Disease (HFMD), and to provide medical evidence of Reduning Injection for HFMD, especially to offer suggestions in clinical practice.

Conditions

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Hand, Foot and Mouth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Western therapy

Group Type ACTIVE_COMPARATOR

Western therapy

Intervention Type OTHER

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.

Reduning Injection

Group Type EXPERIMENTAL

Reduning Injection

Intervention Type OTHER

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.

Reduning Injection plus western therapy

Group Type EXPERIMENTAL

Reduning Injection plus western therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination.
* Less than 48 hours of occurrence of mild symptoms, with an armpit temperature of more than 37.5 degrees Celsius.
* Less than 48 hours of occurrence of tetter or herpes.
* Age of 1-13 years.
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria

* Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc.
* With history of allergies on the experimental medicine, or severe allergies to other medicines.
* Using other western medicine or Chinese medicine for treating HFMD when consulted.
* 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

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Beijing University of Chinese Medicine

OTHER

Sponsor Role collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Jiangsu Kanion Pharmaceutical Co.,Ltd

Principal Investigators

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Wei Xiao

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Kanion Pharmaceutical Co., Ltd

Locations

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An'Hui Provincial Children's Hospital

Hefei, An'Hui, China

Site Status RECRUITING

Fujian Provincial Quanzhou City Children's Hospital

Quanzhou, Fujian, China

Site Status RECRUITING

The Fifth Hospital of Shijiazhuang City

Shijiazhuang, Hebei, China

Site Status RECRUITING

Kaifeng Municipal Children's Hospital

Kaifeng, Henan, China

Site Status RECRUITING

Hunan Provincial Children's Hospital

Changsha, Hunan, China

Site Status RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Biquan Chen

Role: primary

13856065978

Zhiqiang Zhuo

Role: primary

13905984912

Haojie Zheng

Role: primary

13933872363

Xi Zhang

Role: primary

13069307700

Shuangjie Li

Role: primary

15874162057

Yongping Mu

Role: primary

13818869248

Other Identifiers

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200907001-3-1

Identifier Type: -

Identifier Source: org_study_id

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