Trial | NCT01769794  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    jinlianqingre ...

  • Study Participants

    288
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).
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.
Study Started
Jun 30
2011
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Jan 17
2013
Estimate

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℃)

  • Other names: Jinlianqingre Effervescent Tablets

Drug Placebo(for JET)

placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)

Western therapy & Placebo Active Comparator

Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )

Western therapy & JET Experimental

Jinlianqingre Effervescent Tablets plus western therapy

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.
No Results Posted