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 ]
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