CTRI/2014/12/005294

Trial name or title	A comparative randomised controlled trial of homoeopathy and allopathy in acute otitis media and its recurrence in children
Methods	NB: unpublished trial ‐ all information from clinical trial registry record Randomised, parallel‐group, placebo‐controlled trial of homeopathy for AOM Computer‐generated randomisation Open label
Participants	Inclusion criteria: Children of both sexes, aged 2 to 12 years Earache of no more than 36 hours Pain in ear with or without fever Fullness/heaviness in ear with or without signs of URTI History of episode of AOM with proper record of diagnosis in last 1 year Tympanic membrane bulging with loss of landmarks Exclusion criteria: History of convulsions Subperiosteal abscess of mastoid Gross deviated nasal septum Any discharge or history of discharge from ear Suspected cases of adenoids (presenting with persistent nasal discharge, snoring, and chronic history of tonsillar hypertrophy) Otitis media with effusion Child on antibiotics in the past 7 days Child on steroid treatment Child suffering from any systemic disease
Interventions	Homeopathy: individualised homeopathic medicine shall be given in centesimal potency (6c, 30c, 200c, or 1M potency) to be taken orally as per the prescribing totality of the case for a period 3 days. If the child does not improve by more than 50%, antibiotics shall be prescribed as per the discretion of the ENT consultant, after which individualised homeopathic medicine shall be given for a period of 1 year for assessing the recurrence. Allopathy: allopathic medicine such as antipyretics for fever analgesics, anti‐allergic will be given symptomatically for 3 days as per the prescription of the ENT consultant. If the child does not improve within 3 days, antibiotics shall be administered for period of 5 days as per the discretion of the ENT consultant.
Outcomes	Changes in Tympanic Membrane Examination scale and AOM‐SOS scale Time to improvement in pain through FACES Pain Scale‐Revised between the groups Recurrence (number of episodes, intensity, duration) of AOM between the groups Usage of antibiotics in both groups Improvement in quality of life of children as evident from the OM‐6 Health Related Quality of Life scale at baseline, 6 months, and 12 months
Starting date	29 August 2014
Contact information	Dr Praveen Oberai oberai.praveen@gmail.com Dr RK Manchanda dgccrh@gmail.com
Notes

AOM: acute otitis media AOM‐SOS: Acute Otitis Media Severity of Symptoms ENT: ear, nose, and throat ESR: erythrocyte sedimentation rate LRTI: lower respiratory tract infection URTI: upper respiratory tract infection