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A Multicenter, Contrasted Clinical Study on Efficacy and Safety of Recombinant Human Interferona2b Spray in the Treatment of Hand-foot-and --mouth Disease in Kids

A Multicenter, Contrasted Clinical Study on Efficacy and Safety of Recombinant Human Interferona2b Spray in the Treatment of Hand-foot-and --mouth Disease in Kids

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17013182
Enrollment
Unknown
Registered
2017-10-31
Start date
2015-05-12
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hand, foot and mouth disease

Interventions

rhIFNa2b Group:rhIFNa2b spray
ribavirin group:ribavirin spray

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) in accordance with the ministry of health "hand-foot-mouth disease diagnosis and treatment guidelines, 2010" diagnostic criteria of HFMD patients in period I; (2) aged 1-7 years old boys and girls; (3) within 48 hours; (4) no antiviral drugs were used in the previous course of the group; (5) main organs (heart, liver and kidney) have normal functions; (6) the patient carefully read the informed consent and volunteered to participate in the project.;Inclusion criteria: (1) in accordance with the ministry of health "hand-foot-mouth disease diagnosis and treatment guidelines, 2010" diagnostic criteria of HFMD patients in period I; (2) aged 1-7 years old boys and girls; (3) within 48 hours; (4) no antiviral drugs were used in the previous course of the group; (5) main organs (heart, liver and kidney) have normal functions; (6) the patient carefully read the informed consent and volunteered to participate in the project.;Inclusion criteria: (1) in accordance with the ministry of health "hand-foot-mouth disease diagnosis and treatment guidelines, 2010" diagnostic criteria of HFMD patients in period I; (2) aged 1-7 years old boys and girls; (3) within 48 hours; (4) no antiviral drugs were used in the previous course of the group; (5) main organs (heart, liver and kidney) have normal functions; (6) the patient carefully read the informed consent and volunteered to participate in the project.;Inclusion criteria: (1) in accordance with the ministry of health "hand-foot-mouth disease diagnosis and treatment guidelines, 2010" diagnostic criteria of HFMD patients in period I; (2) aged 1-7 years old boys and girls; (3) within 48 hours; (4) no antiviral drugs were used in the previous course of the group; (5) main organs (heart, liver and kidney) have normal functions; (6) the patient carefully read the informed consent and volunteered to participate in the project.;Inclusion criteria: (1) in accordance with the ministry of health "hand-foot-mouth disease diagnosis and treatment guidelines, 2010" diagnostic criteria of HFMD patients in period I; (2) aged 1-7 years old boys and girls; (3) within 48 hours; (4) no antiviral drugs were used in the previous course of the group; (5) main organs (heart, liver and kidney) have normal functions; (6) the patient carefully read the informed consent and volunteered to participate in the project.

Exclusion criteria

Exclusion criteria: (1) history of interferon allergy; (2) severe hand-foot-mouth disease; (3) other antiviral drugs (such as ribavirin, acyclovir, etc.) have been used; (4) there are other serious diseases such as cardiac insufficiency, respiratory insufficiency, hepatic and renal insufficiency and severe malnutrition; (5) having epilepsy or other central nervous system dysfunction; (6) the researcher considers it inappropriate to participate in this experiment.;Exclusion criteria: (1) history of interferon allergy; (2) severe hand-foot-mouth disease; (3) other antiviral drugs (such as ribavirin, acyclovir, etc.) have been used; (4) there are other serious diseases such as cardiac insufficiency, respiratory insufficiency, hepatic and renal insufficiency and severe malnutrition; (5) having epilepsy or other central nervous system dysfunction; (6) the researcher considers it inappropriate to participate in this experiment.;Exclusion criteria: (1) history of interferon allergy; (2) severe hand-foot-mouth disease; (3) other antiviral drugs (such as ribavirin, acyclovir, etc.) have been used; (4) there are other serious diseases such as cardiac insufficiency, respiratory insufficiency, hepatic and renal insufficiency and severe malnutrition; (5) having epilepsy or other central nervous system dysfunction; (6) the researcher considers it inappropriate to participate in this experiment.;Exclusion criteria: (1) history of interferon allergy; (2) severe hand-foot-mouth disease; (3) other antiviral drugs (such as ribavirin, acyclovir, etc.) have been used; (4) there are other serious diseases such as cardiac insufficiency, respiratory insufficiency, hepatic and renal insufficiency and severe malnutrition; (5) having epilepsy or other central nervous system dysfunction; (6) the researcher considers it inappropriate to participate in this experiment.;Exclusion criteria: (1) history of interferon allergy; (2) severe hand-foot-mouth disease; (3) other antiviral drugs (such as ribavirin, acyclovir, etc.) have been used; (4) there are other serious diseases such as cardiac insufficiency, respiratory insufficiency, hepatic and renal insufficiency and severe malnutrition; (5) having epilepsy or other central nervous system dysfunction; (6) the researcher considers it inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
The total efficiency ;

Secondary

MeasureTime frame
The disappearance time of fever;the appetite improvement ; the disappearance times of oral herpes; the disappearance times of rash;

Countries

China

Contacts

Public ContactXingwang Li;Xingwang Li;Xingwang Li;Xingwang Li;Xingwang Li ;;;;

Beijing Ditan Hospital, Capital Medical University;Beijing Ditan Hospital, Capital Medical University;Beijing Ditan Hospital, Capital Medical University;Beijing Ditan Hospital, Capital Medical University;Beijing Ditan Hospital, Capital Medical University

ditanlxw@163.com;ditanlxw@163.com;ditanlxw@163.com;ditanlxw@163.com;ditanlxw@163.com+86 10-84322585;+86 10-84322585;+86 10-84322585;+86 10-84322585;+86 10-84322585

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026