A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Hand, Foot and Mouth Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182532
• Other study ID #: 200907001-3
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: July 20, 2012
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Other:
• Western therapy
Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius; Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;

Drug:
• TCM Syndrome Differentiation and Treatment
Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint. Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc. Dosage: Adjusting by age and weight of patients. Decoction. Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint. 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.

Other:
• Western therapy plus TCM treatment
Symptomatic treatment using the same treatment methods in western therapy group; Syndrome differentiation and treatment adopting the same methods in TCM treatment group.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing You-An Hospital	Beijing	Beijing
China	Changchun Infectious Diseases Hospital	Changchun	Jilin
China	Chengdu Hospital for Infectious Diseases	Chengdu	Sichuan
China	Chongqing Hospital of Traditional Chinese Medicine	Chongqing	Chongqing
China	Fuzhou Infectious Disease Hospital	Fuzhou	Fujian
China	The Sixth People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	Anhui Provincial Children's Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui College of Traditional Chinese Medicine	Hefei	Anhui
China	Huhehaote Second Hospital	Huhehaote	Inner Mongolia
China	First Affiliated Hospital to Kunming Medical College	Kunming	Yunnan
China	First Hospital of Lanzhou University	Lanzhou	Gausu
China	Ninth Hospital of Nanchang	Nanchang	Jiangxi
China	Shanghai Public Health Center	Shanghai	Shanghai
China	Shenzhen Third People's Hospital	Shenzhen	Guangzhou
China	The Fifth Hospital of Shijiazhuang, Hebei	Shijiazhuang	Hebei
China	Xinjiang Hongxing Hospital	Urumuqi	Xinjiang
China	Wuhan Hospital for Infectious Diseases	Wuhan	Hubei
China	The Eighth Hospital of Xi'an City	Xi'an	Shaanxi
China	Xiamen Hospital of Traditional Chinese Medicine	Xiamen	Fujian
China	Ningxia Hui Autonomous Region Forth People's Hospital	Yinchuan	Ningxia Hui Autonomous

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to onset	Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.	10 days	No
Primary	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	No
Secondary	time of symptom disappearance	Refering to the length of time when clinical symptoms and signs totally disappere after the medicine is used.	10 days	No
Secondary	case severity rate	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.	10 days	No
Secondary	time of tetter and oral ulcer disappearance	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.	10 days	No
Secondary	direct medical cost	Referring to the costs in the treatment of HFMD and relative disease, including the registration fee, examination fee, and drug fees, etc.	10 days	No
Secondary	safety outcome	Calculated by adverse event.	10 days	Yes