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NCT Number: NCT01769794

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).

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Key information

Conditions

Hand, Foot and Mouth Disease Body Temperature Changes Coxsackievirus Infections Enterovirus Infections Fever Infections Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Signs and Symptoms Virus Diseases

Age range

1 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tangshan infectious disease hospital, Tangshan, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Western therapy

Drug

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

JET

Drug

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

Placebo(for JET)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. the length of hospital stay

    Time frame: 10 days

  4. major complications rate

    Time frame: 10 days

    Referring to pulmonary edema, cardiac damage, pneumonia, secondary infection, meningitis, encephalomyelitis et al.

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

  • Beijing Children's Hospital
  • Chengdu University of Traditional Chinese Medicine
  • Tangshan infectious disease hospital
  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  • Tianjin Zhongshenghaitian Pharmaceutical Co. Ltd.
  • Tianjin infectious disease hospital

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2013
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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