Otitis Media with Effusion in Children
Conditions
Interventions
Treatment group:0.05% oxymetazoline hydrochloride nasal spray, 1 spray/nostril, once each in the morning and evening, for 1 week
amoxicillin 40mg/kg/d, administered in 3 portions, for 2 weeks
Myrtol standardized enteric-coated capsule, 120mg/capsule/each time, tid, for 12 weeks.
placebo :0.05% oxymetazoline hydrochloride nasal spray, 1 spray/nostril, once each in the morning and evening, for 1 week
placebo capsule, 1 capsule/each time, tid, for 12 weeks.
Sponsors
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. aged 4~12, male or female; 2. Chief complaints: ear fullness, hearing loss; 3. Electric otoscopy showed tympanic depression with or without effusion; 4. Audiometry indicated conductive hearing impairment; 5. Acoustic immitance "B" or C-shaped curve (peak pressure point exceeded -100daPa); 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute infective inflammation in the ears; 2. Subjects who had history of Adenoidectomy or grommet insertion; 3. Severe heart, liver, kidney, lung diseases or congenital diseases; 4. hypersensitive to myrtol standardized, Penicillins,cephalosporins, furans,Clavulanic acid and ephedrine; 5. Use of drugs that may potentially affect the trial results and drug discontinuance is shorter than the required interval; 6. Participation in other drug clinical trial within 3 months; 7. Other conditions that my affect efficacy evaluation in investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acoustic immitance;Pure tone audiometry;3.Signs of tympanic membrane;subjective symptom; | — |
Countries
China
Contacts
Public ContactWeijia Kong, Sulin Zhang
Outcome results
None listed