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A Multicentre, Randomized, Positive Medicine Controlled Trial for Recombinant Human Interferon-a2b Spray (pseudomonas) in the Treatment of Acute Upper Respiratory Tract Infection in Children

A Multicentre, Randomized, Positive Medicine Controlled Trial for Recombinant Human Interferon-a2b Spray (pseudomonas) in the Treatment of Acute Upper Respiratory Tract Infection in Children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020373
Enrollment
Unknown
Registered
2018-12-27
Start date
2019-01-15
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

acute upper respiratory tract infection in children

Interventions

Interferon spray group:Recombinant human interferon alpha 2b spray
Ribavirin aerosol group:Ribavirin aerosol

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) aged 1 to 14 years old male and female children; (2) axillary temperature is 37.5 degree C or higher; (3) in accordance with the "Zhu Futang Practice of Pediatrics" diagnostic criteria of upper respiratory tract infection; (4) visit the doctor within 72 hours after the occurrence of upper respiratory tract infection; (5) routine blood test and/or CRP examination results suggest viral infection; (6) previous health, no underlying disease or complications; (7) the patient carefully read the informed consent and volunteered to participate in the project.

Exclusion criteria

Exclusion criteria: (1) more than 72 hours after onset; (2) bacterial infection or mycoplasma infection were suggested; (3) confirmed influenza patients; (4) patients with pertussis, scarlet fever, measles, poliomyelitis, encephalitis and other acute infectious diseases; (5) allergic to the research drugs and accessories; (6) have been treated with antiviral drugs in the course of disease (such as other interferons, ribavirin, tibifidine, ganciclovir, acyclovir, deoxyaplovir, etc.); (7) patients with severe lower respiratory tract infection; (8) the following chronic diseases exist: chronic bronchitis, bronchial asthma, bronchiectasis, obstructive pulmonary disease (COPD), coronary heart disease, chronic cardiac insufficiency, seasonal allergic asthma; (9) patients with liver, kidney and heart dysfunction (abnormal index value exceeds the upper limit of standard value by 1.5 times); (10) severe malnutrition and immunodeficiency; (11) patients with familial hypertrophy of tonsils; (12) the researcher considers it inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Body temperature;

Secondary

MeasureTime frame
Nasal obstruction;Nasal discharge;Sneeze;Sore throat;Pharyngeal hyperemia;Cough;Swelling of tonsil;

Countries

China

Contacts

Public ContactYunxiao SHANG

Shengjing Hospital of China Medical University

shangyunx@sina.com+86 18940251827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026