Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study

Hand, Foot and Mouth Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769794
• Other study ID #: ChinaACMS-HFMD
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 16, 2013
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Drug:
• Western therapy
Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5?. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form
• JET
4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature=38.5?)
• Placebo(for JET)
placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)

Locations

Country	Name	City	State
China	Beijing children's hospital	Beijing
China	Affiliated Hospital of Chengdu university of Traditional Chinese Medicine	Chengdu	Sichuan
China	Tangshan infectious disease hospital	Tangshan	Hebei
China	Tianjin infectious disease hospital	Tianjin

Sponsors (7)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing Children's Hospital, Chengdu University of Traditional Chinese Medicine, Tangshan infectious disease hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Tianjin infectious disease hospital, Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of body temperature going back to normal	Referring 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	Yes
Secondary	Healing time of skin or oral mucosa lesions symptom	Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.	10 days	Yes
Secondary	Score of skin or oral mucosa lesions symptom during the study period time	Referring to Symptoms were hands, feet, oral mucosa lesions, buttock, crissum, back and four limbs. Each symptom was scored as 0 (none), 1 (mild), 2 (modest), or 3 (severe).	10 days	Yes
Secondary	the length of hospital stay		10 days	Yes
Secondary	major complications rate	Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.	10 days	Yes