Condition category
Ear, Nose and Throat
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Secretory otitis, commonly referred to as glue ear, is a childhood condition where fluid (mucus) builds up in the middle ear. This can cause hearing problems and affect the child’s social adaptation and academic performance. The mucus can just stay in the ear, can cause a hole to develop in the eardrum (perforated eardrum), or can cause an ear infection (acute otitis media), which would require treatment with antibiotics. The recent guidelines concluded that there is no single effective treatment for secretory otitis, and recommend a period of three months of monitoring during which the secretory otitis may improve spontaneously. If there is no improvement after 3 months, surgical treatment may be required to place tubes (grommets) in the ear to drain the mucus, with or without adenoidectomy (an operation to remove the adenoids). The aim of this study is to assess the effectiveness of homeopathy as an addition to the conventional treatment for children with secretory otitis.

Who can participate?
Children age 2 months to 12 years with secretory otitis

What does the study involve?
Participants are randomly allocated into two groups. One group receives homeopathic treatment and the other group receive a placebo (dummy drug). Both groups also receive conventional treatment (budesonide and ambroxol hydrochloride in an aerosol [spray]) for 20 days at a rate of one session per day.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Complejo Hospitalario de Toledo (Spain)

When is the study starting and how long is it expected to run for?
September 2012 to January 2014

Who is funding the study?
University of Zaragoza (Spain)

Who is the main contact?
María Fernanda Pedrero Escalas

Trial website

Contact information



Primary contact

Dr María Fernanda Pedrero


Contact details

Hospital Virgen de la Salud de Toledo
Otorrinilogy Service
Av. de Barber
+34 (0)687 468 806

Additional identifiers

EudraCT number

2011-006086-17 number

Protocol/serial number


Study information

Scientific title

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: a randomized parallel double-blind clinical trial


Study hypothesis

The coadjuvancy with homeopathy, in patients aged 2 months to 12 years, can improve or resolve the SO, diagnosed through the Bilateral pneumatic otoscopy (OPN), the primary endpoint being a dichotomous one (positive or negative mobility of the tympanic membrane).

Ethics approval

RCREC of Toledo, Hospital of Toledo (RCREC of Toledo, Complejo Hospitalatio de Toledo), 16/01/2012

Study design

Controlled randomized (1:1) parallel double-blind clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact María Fernanda Pedrero Escalas [] to request a patient information sheet


Secretory otitis in childhood


Control arm receives
Aerosolot: 1 session / 24 hours / 20 days with: 1 vial of Ambroxol hydrochloride 7.5 mg/ml, 1 vial of budesonide 0.25 mg/ml suspension, and 2cc of physiological saline.

Intervention arm receives aerosol + A or B.
Aerosolot: 1 session / 24 hours / 20 days with: 1 vial of Ambroxol hydrochloride 7.5 mg/ml, 1 vial of budesonide 0.25 mg/ml suspension, and 2cc of physiological saline.

A: Agraphis nutans 5CH (granules) and Thuya occidentalis 5CH (granules) 5 granules once a day, preferably in the evening. Approximately 80 pellets are in each tube
B: Kalium muriaticum 9CH (granules) and Arsenicum iodatum 9CH (granules) 5 granules, twice a day. Approximately 80 pellets are in each tube.

Intervention type



Not Applicable

Drug names

Primary outcome measure

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

Secondary outcome measures

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
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)
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)
4. The proportion and type of intercurrent adverse events will be collected during the trial in both study groups

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

220 subjects

Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital Virgen de la Salud de Toledo

Sponsor information


Individual sponsor (Spain)

Sponsor details

Dr. María Fernanda Pedrero Escalas
Hospital Virgen de la Salud de Toledo
Otorrinology Service
Av. de Barber
+34 (0)687 468 806

Sponsor type




Funder type


Funder name

Universidad de Zaragoza

Alternative name(s)

University of Zaragoza, UNIZAR

Funding Body Type

government organisation

Funding Body Subtype

Local government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/08/2016: Plain English summary added.