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| 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 |
| ISRCTN | ISRCTN11416813 |
| DOI | 10.1186/ISRCTN11416813 |
| ClinicalTrials.gov identifier | |
| EudraCT number | 2011-006086-17 |
| Public 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 |
| 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 | N/A |
| Serial number at source | 55005646 |
| 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). |
| Lay summary | Lay summary under review 2 |
| Ethics approval | RCREC of Toledo, Hospital of Toledo (RCREC of Toledo, Complejo Hospitalatio de Toledo), 16 January 2012 |
| Study design | Controlled randomized (1:1) parallel double-blind clinical trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Secretory Otitis in childhood |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 30/09/2012 |
| Anticipated end date | 31/01/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact María Fernanda Pedrero Escalas [mf.pedrero@gmail.com] to request a patient information sheet |
| Target number of participants | 220 subjects |
| Interventions |
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 Homeopatic: 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. |
| Primary outcome measure(s) | The presence or absence of secretory otitis in childhood depending on the tympanic mobility measured with pneumatic otoscopy |
| Secondary outcome measure(s) |
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 |
| Sources of funding | University of Zaragoza (Spain) |
| Trial website | |
| Publications | |
| Contact name | Dr María Fernanda Pedrero |
| Address |
Hospital Virgen de la Salud de Toledo
Otorrinilogy Service Av. de Barber, 30 |
| City/town | Toledo |
| Zip/Postcode | 45071 |
| Country | Spain |
| Tel | +34 687 468 806 |
| mf.pedrero@gmail.com | |
| Sponsor | Individual sponsor (Spain) |
| Address |
Dr. María Fernanda Pedrero Escalas
Hospital Virgen de la Salud de Toledo Otorrinology Service Av. de Barber, 30 |
| City/town | Toledo |
| Zip/Postcode | 45071 |
| Country | Spain |
| Tel | +34 687 468 806 |
| mf.pedrero@gmail.com | |
| Date applied | 17/10/2012 |
| Last edited | 26/02/2013 |
| Date ISRCTN assigned | 26/02/2013 |
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