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

NCT01175915 | Unknown DMC

• 1 other identifier: 200907001-3-1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Mild type of hand, foot and mouth disease; Reduning Injection; Effectiveness; Safety

Outcome Measures

Primary Outcomes (2)

• time of bringing down the fever

  Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

  10 days

• time of body temperature going back to normal

  Refering to the time of the armpit temperature of lower than 37.0 degrees Celsius, lasting for at least 24 hours, after the medicine is taken.

  10 days

Secondary Outcomes (5)

• time of symptom disappearance

  10 days

• time of tetter disappearance

  10 days

• dose and usage of medicine

  10 days

• case severity rate

  10 days

• adverse reaction incidence

  10 days

Study Arms (3)

Western therapy

ACTIVE COMPARATOR

Other: Western therapy

Reduning Injection

EXPERIMENTAL

Other: Reduning Injection

Reduning Injection plus western therapy

EXPERIMENTAL

Other: Reduning Injection plus western therapy

Interventions

Western therapy 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.

Western therapy

Reduning Injection 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

Reduning Injection plus western therapy 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.

Reduning Injection plus western therapy

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Kanion Pharmaceutical Co., Ltd: lead
• Beijing University of Chinese Medicine: collaborator

Study Sites (6)

An'Hui Provincial Children's Hospital

Hefei, An'Hui, China

RECRUITING

Fujian Provincial Quanzhou City Children's Hospital

Quanzhou, Fujian, China

RECRUITING

The Fifth Hospital of Shijiazhuang City

Shijiazhuang, Hebei, China

RECRUITING

Kaifeng Municipal Children's Hospital

Kaifeng, Henan, China

RECRUITING

Hunan Provincial Children's Hospital

Changsha, Hunan, China

RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Hand, Foot and Mouth Disease; Mouth Diseases

Interventions

reduning

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases

Study Officials

• Wei Xiao

  Jiangsu Kanion Pharmaceutical Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 5, 2010

Record last verified: 2010-08

Locations

CN (6)