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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: China Academy of Chinese Medical Sciences

Current Primary Outcome: The time of body temperature going back to normal [ Time Frame: 10 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Healing time of skin or oral mucosa lesions symptom [ Time Frame: 10 days ]
    Referring to the number of days in the total-contact cast until the skin completely closed after the medicine is used.
  • Score of skin or oral mucosa lesions symptom during the study period time [ Time Frame: 10 days ]
    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).
  • the length of hospital stay [ Time Frame: 10 days ]
  • major complications rate [ Time Frame: 10 days ]
    Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.


Original Secondary Outcome: Same as current

Information By: China Academy of Chinese Medical Sciences

Dates:
Date Received: January 15, 2013
Date Started: June 2011
Date Completion:
Last Updated: January 16, 2013
Last Verified: January 2013