Hand-foot-mouth disease
Conditions
Interventions
Treatment group A:General treatment involves physical cooling for all three groups of pediatric patients. If the body temperature exceeds 38.5°C, ibuprofen suspension (5–10 mg/kg) may be administered
1–3 years: 2–3 g per dose
4–6 years: 3–4 g per dose
7–9 years: 4–5 g per dose
10 years and older: 6 g per dose. Take three times daily.
Treatment group C:General treatment plus Xiaoer Chiqiao Qingre Syrup: Oral administration. Dosage and administration: 6 months to 1 year: 10 ml per dose
1 to 3 years: 15 ml per dose
4 to 6 years: 20 ml per dose
7 to 9 years: 25 ml per dose
10 years and above: 30 ml per dose
Three times daily.
In comparison with Group B:Usage and dosage of general treatment + Xiaoer Chiqiao Qingre Syrup simulator: take with boiling water. 6 months to 1 year: 1-2G at a time
1-3 years old: 2-3g at a time
4-6 years old: 3-4g at a time
7-9 years: 4-5g at a time
Over 10 years old: 6g at a time
Three times a day.
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1) Children aged 0.5-14 years, with no restriction on gender; 2) Clinically diagnosed or confirmed as having the common type of hand, foot, and mouth disease within the past 48 hours; 3) The patient has not received any immunosuppressive agents, hormones, or antiviral medications (including both traditional Chinese and Western medicine) within the 24 hours prior to treatment; 4) The parents of the participants are fully informed about the study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with drug allergies being studied; 2) Patients with cardiovascular diseases or dysfunction of important organs such as the liver or kidneys, or other systemic organic diseases; 3) Patients with other exanthematous diseases caused by viral infections such as measles, rubella, and chickenpox; 4) Patients with other contraindications (e.g., spleen and stomach deficiency, loose stools, diabetic patients, etc.) and those who cannot fully cooperate with treatment; 5) Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total effective rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Onset of Resolution of Skin Rash or Vesicles;individual traditional symptoms of clinical efficacy;Adverse Event Rate;Traditional Chinese Medicine symptom efficacy;Investigational Product Adherence Rate;Patient-Reported Willingness for Treatment Reinitiation Assessment;Time to Complete Resolution of Skin Rash/Vesicles and Oral Mucosal Vesicles/Ulcers Following Treatment Initiation; | — |
Countries
China
Contacts
Public ContactLi Zailin
Peking University Third Hospital
Outcome results
None listed