Health TrialsbyHealthPanel

Acetic Acid Ear Drops Versus 0.3 % Ciprofloxacin for Chronic Suppurative Otitis Media.

ConditionOtitis Media Chronic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDow University of Health Sciences

About this trial

This randomized controlled trial aims to compare the effectiveness of 2% acetic acid ear drops with 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media (CSOM). The study will be conducted among adults aged 18 to 70 years attending the Otorhinolaryngology Department of Dr. Ruth K.M. Pfau Civil Hospital, Karachi. Participants will be randomly allocated to receive either 2% acetic acid or 0.3% ciprofloxacin ear drops three times daily for one month. Treatment effectiveness will be assessed by achievement of a dry ear and improvement in otological symptom score.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years

Either sex

Persistent, non-foul-smelling ear discharge for ≥3 months

Tubotympanic type chronic suppurative otitis media

Disqualifiers

Immunocompromised patients

External auditory canal pathology

Ear malignancy

Known hypersensitivity to acetic acid or ciprofloxacin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetic Acid 2% Ear Drops

    Drug

    2% acetic acid ear drops, 3 drops administered into the affected ear three times daily for one month. Participants will self-administer the assigned medication after appropriate instructions.

  • Ciprofloxacin 0.3% Otic Solution

    Drug

    0.3% ciprofloxacin otic solution, 3 drops administered into the affected ear three times daily for 30 days. Participants will self-administer the medication after appropriate instructions.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: 2% Acetic Acid Ear DropsExperimental treatment 1 intervention
Group B: 0.3% Ciprofloxacin Ear DropsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dry ear status after 30 days.

Proportion of participant with a dry ear: defined as absence of moisture or ear discharge on clinical examination with an otological symptom score of ≤2 after 30 days of initial treatment.

Time frame
30 days after intial treatment

Secondary outcomes

1

Ear discharge status

Presence and severity of ear discharge assessed clinically at each follow-up visit

Time frame
7, 14 and 30 days after the initiation of treatment
2

Otological symptom score

Otological symptoms of patient like reduction of discharge , ear itching and other study specified symptoms assessed using the predefined otological symptom score.

Time frame
7, 14 and 30 days after the initiation of treatment
3

Treatment adherence and tolerability

Treatment adherence assessed by partcipant-reported use of the study medication , and tolerability assessed by recording adverse symptoms or local reactions asssociated with the treatment.

Time frame
30 days after initiation of treatment.
4

ear discharge status at followup.

Presence or absence of ear discharge on clinical examination following completion of treatment period.

Time frame
30 days after completion of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dow University of Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: