A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 1 year to 13 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

6 sites in 1 country.

About this study

Conditions

Hand, Foot and Mouth Disease

Being tested

Western therapy, Reduning Injection, Reduning Injection plus western therapy

Keywords

Mild type of hand, foot and mouth disease, Reduning Injection, Effectiveness, Safety

Medical subject headings

Hand, Foot and Mouth Disease, Mouth Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Western therapyOther

  1. Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
  2. Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius lasting for more than 2 hours;
  3. No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes.

  Intervention time: 3-7 days; Follow-up time: 3 days.

• Reduning InjectionOther

  1. Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics;
  2. Reduning Injection, 0.5~15ml, depending on patient's condition, IV per day, or according to the instruction;
  3. Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours.

  Intervention time: 3-7 days; Follow-up time: 3 days.

• Reduning Injection plus western therapyOther

  1. General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows;
  2. Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group;
  3. Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group.

  Intervention time: 3-7 days; Follow-up time: 3 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. time of bringing down the fever

   Refering to the length of time to bring down the fever by 0.5 degrees Celsius after the medicine is taken.

   Measured: 10 days

2. time of body temperature going back to normal

   Refering 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.

   Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted5 Aug 2010 (estimated)
2. Study startMay 2010
3. Primary completionAug 2010 (estimated)
4. Study completionAug 2010 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.