Pediatric patients aged 2 months to 12 years presenting secretory otitis MedDRA version: 14.1 Level: PT Classification code 10033072 Term: Otitis externa System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AGRAPHIS NUTANS 5 CH
Product Name: AGRAPHIS NUTANS 5CH
Pharmaceutical Form: Granules
INN or Proposed INN: AGRAPHIS NUTANS 5CH
Current Sponsor code: AGRAPHIS NUTANS 5CH
Concentration unit:
Sponsors
Maria Fernanda Pedrero Escalas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: 2 months - 12 years - Informed consent from parents / guardians - OS unilateral or bilateral consultations ENT diagnosed with pneumatic otoscopy as the presence or absence of tympanic mobility. Each ear will count as one unit primary endpoint. - Not following any standard treatment, namely mainly steroids, antihistamines and mucolytics. Are the trial subjects under 18? yes Number of subjects for this age range: 220 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - AOM or complicated at the time of baseline - Not have passed the newborn hearing screenig (OAE) - Concomitant diseases, - Sensorineural hearing loss permanent - Autism - Down Syndrome or other craniofacial malformations, - Malformations of the outer or middle ear - Acute Mastoiditis and Cholesteatoma - Vaccination recent (less than 30 days) - Cilial motility disorders (Kartagener syndrome) - Language Alterations or prelingual speech - OSA - Prior Adenoidectomy - Persistence of DTT or perforated eardrum - Lactose intolerance or diabetes (incompatible with placebo and homeopathy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of homeopathy coadyuvancia of aerosol treatment (mucolytics, corticosteroids), secretory otitis in pediatric patients 2 months to 12 years, making an intervention group who receive homeopathy and the control group will receive placebo. It will compare the effectiveness measured by pneumatic otoscopy;Secondary Objective: Coadyuvancia assess whether homeopathy could: ? reduce the number of surgeries (ear tubes (DTT) + / - adenoidectomy) and costs associated therewith ? reduce intercurrent acute otitis media (AOM), tympanic perforations or complicated acute otitis media during the course of the study. ? reduce truancy or parental occupation in relation to intercurrent AOM ? assess the safety of both treatments;Primary end point(s): Bilateral pneumatic otoscopy (BPO): improvement or resolution of secretory otitis, tympanic mobility based on using the pneumatic otoscope (Halogen HPX insufflation with No. 25021 Welch Allyn). The test we consider our main result, to be negative when there is no tympanic mobility (secretory otitis presence) and positive when tympanic mobility (no secretory otitis). Taking into account the mobility tympanic narrowly, leaving aside other (color, appearance of the eardrum) increases the sensitivity and specificity to 95%, 85%, respectively. (6). Each ear was assessed separately, the main variable in the case of subjects with bilateral OS;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? bilateral Impedance: Jerger classification. This classification is based on the study of tympanic impedance curve (Model GSI-Auto-Tymp Version 2). Are three subtypes of curve A, B and C. Only Type B, plane curve, is considered suggestive of occupation of the middle ear by fluid (otitis secretory) (6). Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. ? bilateral optical microscope: in order to visualize features of the tympanic membrane and middle ear characteristics such as amber, delustrado, bulging, or retraction fluid level shall be considered suggestive of secretory otitis. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. ? Acute otitis media: occupation of the middle ear for signs of mucus associated with inflammation of the tympanic membrane. We will assess the number of acute otitis media or bilateral breakthrough, defined as ear pain and / or otorrhea, or has been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied treatment at any time for currently used in our hospital. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. ? Acute Mastoiditis: mastoid osteitis with risk of spread to adjacent structures secondary to acute otitis media, which has been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied treatment at any time for currently used in our hospital. Each ear was assessed separately, the main variable in the case of subjects with bilateral OS. ? tympanic perforation: disruption of the continuity of the tympanic membrane, which have been diagnosed by a pediatrician, otolaryngologist or primary care physician throughout the study period, without being denied approp | — |
Countries
Spain
Contacts
Public ContactRosa Sanchez
MEDITRIAL
Outcome results
None listed