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

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).

Study Overview

• Status: Completed
• Conditions: Hand, Foot and Mouth Disease
• Intervention / Treatment: Drug: Western therapy; Drug: Placebo(for JET); Drug: JET

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 Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100045
    • Beijing Children's Hospital
  • Tianjin, China, 300192
    • Tianjin Infectious Disease Hospital
  • Hebei
    • Tangshan, Hebei, China, 063020
      • Tangshan infectious disease hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Western therapy & Placebo; Western therapy(oral care, skin care and reducing temperature) Placebo for JET(Jinlianqingre Effervescent Tablets )	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: Placebo(for JET); placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
Experimental: Western therapy & JET; Jinlianqingre Effervescent Tablets plus western therapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of body temperature going back to normal	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.	10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Chengdu University of Traditional Chinese Medicine; Beijing Children's Hospital; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Tianjin infectious disease hospital; Tangshan infectious disease hospital; Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
• Investigators: Study Chair: Boyan Liu, chief physician, China Academy of Chinese Medical Sciences; Study Chair: Guoliang Zhang, chief, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Fever; Enterovirus; Medicine, Chinese Traditional; Hand, Foot and Mouth Disease
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Mouth Diseases; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: ChinaACMS-HFMD