A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
|ClinicalTrials.gov Identifier: NCT01182532|
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : July 23, 2012
|Condition or disease||Intervention/treatment|
|Hand, Foot and Mouth Disease||Other: Western therapy Drug: TCM Syndrome Differentiation and Treatment Other: Western therapy plus TCM treatment|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||December 2011|
|Active Comparator: Western therapy||
Other: Western therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
|Experimental: TCM treatment||
Drug: TCM Syndrome Differentiation and Treatment
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.
Experimental: Western therapy plus TCM treatment
The combination of both western therapy and TCM treatment.
Other: Western therapy plus TCM treatment
- 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.
- time of symptom disappearance [ Time Frame: 10 days ]Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.
- case severity rate [ Time Frame: 10 days ]Refering to the ratio of patient with mild type of HFMD to severe type, such as damage of central nervous system, pulmonary edema, heart failure, respiratory failure, etc.
- time of tetter and oral ulcer disappearance [ Time Frame: 10 days ]Refering to the length of time when the tetter due to HFMD disappears, characterised by no new tetter and oral ulcer develops, scab(s) or dropping; and time of oral ulcer concrescence, etc.
- direct medical cost [ Time Frame: 10 days ]Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.
- safety outcome [ Time Frame: 10 days ]Calculated by adverse event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182532
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|Principal Investigator:||Guoliang Zhang||An'Hui Chinese Medical College Affiliated No.1 Hospital|