NCT02328651

Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease

Effect and Safety of Xiao'er Jiebiao Oral Liquid in Combination With Standard Treatment on Hand-foot-mouth Disease in Pediatric Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

Summary

This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.

Conditions

• Handfoot-mouth Disease

Interventions

Type	Name	Description
DRUG	Ribavirin plus Xiao'er jiebiao oral liquid	For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years. For moderate (Phase II) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\~5ml/kg,iv, Bid\~tid）
DRUG	Ribavirin	For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip. For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2\~5ml/kg, iv, Bid\~tid）

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-04-30
• Completion: 2018-05-31
• First posted: 2014-12-31
• Last updated: 2018-08-07

Locations

1 site across 1 country: China