NCT01769794

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
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
DRUG	JET	4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
DRUG	Placebo(for JET)	placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2013-01-17
• Last updated: 2013-01-17

Locations

4 sites across 1 country: China