A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,000
- Locations
- 21
- Primary Endpoint
- time to onset
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 fever and/or occurrence of tetter or herpes.
- •Age of 1-14 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 traditional Chinese medicine.
- •Patients or their guardians suffering from Psychiatric diseases.
- •Attending other clinical studies on HFMD after diagnosed.
Arms & Interventions
Western therapy
Intervention: Western therapy (Other)
TCM treatment
Intervention: TCM Syndrome Differentiation and Treatment (Drug)
Western therapy plus TCM treatment
The combination of both western therapy and TCM treatment.
Intervention: Western therapy plus TCM treatment (Other)
Outcomes
Primary Outcomes
time to onset
Time Frame: 10 days
Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.
time of body temperature going back to normal
Time Frame: 10 days
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.
Secondary Outcomes
- time of symptom disappearance(10 days)
- case severity rate(10 days)
- time of tetter and oral ulcer disappearance(10 days)
- direct medical cost(10 days)
- safety outcome(10 days)
Investigators
Guoliang Zhang
Chief
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine