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

Not Applicable

Completed

Conditions: Secretory otitis in childhood
Ear, Nose and Throat
Otitis externa

Registration Number: ISRCTN11416813

Lead Sponsor: Individual sponsor (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 220

Inclusion Criteria

1. Age: 2 months - 12 years
2. Informed consent from parents and / or tutors
3. SO diagnosed unilateral or bilateral diagnosed in otolaryngology consultations with pneumatic otoscopy, according to the presence or absence of tympanic mobility. Each ear counted as one unit of primary endpoint.
4. Do not be following any regular treatment, specifically especially corticosteroids, antihistamines and mucolytics

Exclusion Criteria

1. Acute Otitis Media or complicated at the time of baseline
2. Have not passed the newborn hearing screenig (OAE)
3. Concomitant diseases
4. Permanent sensorineural hearing loss
5. Autism
6. Down Syndrome craneofaciales or other malformations
7. Malformations of the outer or middle ear
8. Acute Mastoiditis or Cholesteatoma
9. Recent vaccination (less than 30 days)
10. Cilial motility disorders (Kartagener syndrome)
11. Alterations prelingual speech or language
12. Obstructive sleep apnea (OSA)
13. Adenoidectomy
14. Persistence of Tubo-tympanic disease (TTD) or perforated eardrum
15. Lactose intolerance or diabetes (incompatible with placebo and homeopathy)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence or absence of secretory otitis in childhood depending on the tympanic mobility measured with pneumatic otoscopy

Secondary Outcome Measures

Name	Time	Method
1. Need for surgery (DTT + / - adenoidectomy) in any of the patient's ears with secretory otitis at the end of study to meet the surgical indications of the Spanish Society of Otolaryngology and cervico-facial<br>2. Number of Secretory Otitis Media, Secretory Otitis Media complicated and tympanic perforations in one of the two ears of patients with secretory otitis during the study period (3 months)<br>3. Number of days of absence from school or work, the patient or primary caregivers have been forced to make during the study period (3 months) for reasons related to hearing problems (Secretory Otitis Media, Complications of Secretory Otitis Media or perforated eardrum)<br>4. The proportion and type of intercurrent adverse events will be collected during the trial in both study groups