Condition category
Ear, Nose and Throat
Date applied
17/10/2012
Date assigned
26/02/2013
Last edited
02/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
mf.pedrero@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr María Fernanda Pedrero

ORCID ID

Contact details

Hospital Virgen de la Salud de Toledo
Otorrinilogy Service
Av. de Barber
30
Toledo
45071
Spain
+34 (0)687 468 806
mf.pedrero@gmail.com

Additional identifiers

EudraCT number

2011-006086-17

ClinicalTrials.gov number

Protocol/serial number

55005646

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact María Fernanda Pedrero Escalas [mf.pedrero@gmail.com] to request a patient information sheet

Condition

Secretory otitis in childhood

Intervention

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.

And
Homeopathic:
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
or
B: Kalium muriaticum 9CH (granules) and Arsenicum iodatum 9CH (granules) 5 granules, twice a day. Approximately 80 pellets are in each tube.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

30/09/2012

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Both

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

30/09/2012

Recruitment end date

31/01/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Virgen de la Salud de Toledo
Toledo
45071
Spain

Sponsor information

Organisation

Individual sponsor (Spain)

Sponsor details

Dr. María Fernanda Pedrero Escalas
Hospital Virgen de la Salud de Toledo
Otorrinology Service
Av. de Barber
30
Toledo
45071
Spain
+34 (0)687 468 806
mf.pedrero@gmail.com

Sponsor type

Other

Website

Funders

Funder type

University/education

Funder name

Universidad de Zaragoza

Alternative name(s)

University of Zaragoza

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/08/2016: Plain English summary added.