Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum and Arsenicum iodatum 9CH 9CH) as adjuvant secretory otitis in childre

Conditions: Pediatric patients aged 2 months to 12 years presenting secretory otitis
MedDRA version: 14.1Level: PTClassification code 10033072Term: Otitis externaSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2011-006086-17-ES

Lead Sponsor: Maria Fernanda Pedrero Escalas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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)