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

Not Applicable

Completed

• Conditions: Hand, Foot and Mouth Disease
• Interventions: Drug: Western therapy; Drug: Placebo(for JET); Drug: JET

• Registration Number: NCT01769794
• Lead Sponsor: China Academy of Chinese Medical Sciences

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 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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-16
• Last Update Submitted: 2013-01-16
• Study First Posted: 2013-01-17
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Western therapy & Placebo	Western therapy	Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
Western therapy & Placebo	Placebo(for JET)	Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )
Western therapy & JET	Western therapy	Jinlianqingre Effervescent Tablets plus western therapy
Western therapy & JET	JET	Jinlianqingre Effervescent Tablets plus western therapy

Primary Outcome Measures

Name	Time	Method
The time of body temperature going back to normal	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.

Secondary Outcome Measures

Name	Time	Method
Healing time of skin or oral mucosa lesions symptom	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	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	10 days
major complications rate	10 days	Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.

Trial Locations

Locations (4)

Tangshan infectious disease hospital; 🇨🇳 Tangshan, Hebei, China

Beijing children's hospital; 🇨🇳 Beijing, China

Tianjin infectious disease hospital; 🇨🇳 Tianjin, China

Affiliated Hospital of Chengdu university of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China