Clinical trial NCT01769794: Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand, Foot and Mouth Disease
Keywords: Hand, Foot and Mouth Disease
Medicine, Chinese Traditional
Enterovirus
Fever
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Chengdu University of Traditional Chinese Medicine
name: Beijing Children's Hospital
name: Tianjin infectious disease hospital
name: Tangshan infectious disease hospital
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
First posted: 2013-01-17
Enrollment: 288
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed to evaluate the effectiveness and safety of Jinlianqingre Effervescent Tablets, a traditional Chinese medicine (TCM), in the treatment of Uncomplicated hand, foot, and mouth disease (HFMD).

Detailed description: By adopting a multicenter, prospective, randomized double-blind, placebo-controlled, this study is aimed to evaluate the effectiveness, safety of a traditional Chinese medicine, Jinlianqingre Effervescent Tablets, for treatment Uncomplicated HFMD, and to provide scientific evidence for the construction of TCM methods in treating HFMD.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health;
* Within 48 hours of onset of fever and rash symptom.
* Age of 1-13 years.
* Documented body temperature 37.4 °C-39.0°C
* Patients or their guardians agree to participate in this study and signed the informed consent form.

Exclusion Criteria:

* Complicated with other serious diseases such as chronic hepatitis,chronic diarrhea disease,chronic diarrhea, congenital heart disease, acute or chronic nephritis and blood diseases.
* With history of allergies on traditional Chinese medicine.
* Attending other clinical studies on HFMD after diagnosed.

Primary outcomes:
measure: The time of body temperature going back to normal
timeFrame: 10 days
Secondary outcomes:
measure: Healing time of skin or oral mucosa lesions symptom
timeFrame: 10 days
measure: Score of skin or oral mucosa lesions symptom during the study period time
timeFrame: 10 days
measure: the length of hospital stay
timeFrame: 10 days
measure: major complications rate
timeFrame: 10 days
Other outcomes:
Locations:
city: Tangshan
country: China
facility: Tangshan infectious disease hospital
state: Hebei
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu university of Traditional Chinese Medicine
state: Sichuan
city: Beijing
country: China
facility: Beijing children's hospital
city: Tianjin
country: China
facility: Tianjin infectious disease hospital
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Boyan Liu, chief physician
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Guoliang Zhang, chief
role: STUDY_CHAIR
References: