[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657103":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":33,"armGroups":43,"interventions":56,"overallOfficials":33,"centralContacts":66,"locations":72,"responsibleParty":91,"collaborators":33,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":33,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":33,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":116,"whyStopped":33,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Dow University of Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"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.","30 days after intial treatment",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Ear discharge status","Presence and severity of ear discharge assessed clinically at each follow-up visit","7, 14 and 30 days after the initiation of treatment",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":24},"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.","30 days after initiation of treatment.",{"measure":26,"description":27,"timeFrame":28},"ear discharge status at followup.","Presence or absence of ear discharge on clinical examination following completion of treatment period.","30 days after completion of treatment",{"measure":30,"description":31,"timeFrame":32},"5. Adverse effects associated with treatment","To assess the adverse effects associated with treatment","30 days after initiation of treatment",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR","Background and rationale:\n\nChronic Suppurative Otitis Media (CSOM) is a chronic inflammatory condition of the middle ear and mastoid cavity characterized by persistent or recurrent ear discharge through a perforated tympanic membrane. It is more common in developing countries and can lead to complications including tympanosclerosis, cholesteatoma, and ossicular necrosis if inadequately treated.\n\nCurrent treatment:\n\nTubotympanic CSOM is primarily managed conservatively with aural toilet and topical antimicrobial therapy. Topical ciprofloxacin is commonly used because of its effectiveness against CSOM pathogens and favorable safety profile. However, increasing antibiotic resistance has encouraged the evaluation of alternative topical treatment options.\n\nRationale for acetic acid:\n\nPrevious studies have reported beneficial outcomes with topical acetic acid in patients with CSOM. Acetic acid has also been reported as a potentially cost-effective and readily available alternative treatment. The present study will evaluate whether 2% acetic acid ear drops are effective in achieving a dry ear compared with conventional topical ciprofloxacin therapy.\n\nStudy objective:\n\nThe objective of this study is to compare the effectiveness of 2% acetic acid ear drops versus 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media. Effectiveness will primarily be assessed by achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.\n\nStudy design and setting:\n\nThis is a parallel-group randomized controlled trial with 1:1 allocation. The study will be conducted in the Department of Otorhinolaryngology, Dr. Ruth K.M. Pfau Civil Hospital, Karachi. The study will be conducted over a period of six months following approval from the College of Physicians and Surgeons Pakistan (CPSP) and the Institutional Review Board (IRB) of Dow University of Health Sciences.\n\nStudy population:\n\nThe study will include 146 participants aged 18-70 years with tubotympanic-type CSOM who fulfil the predefined inclusion and exclusion criteria. The calculated sample size was 124 participants (62 per group), with an additional 15% allowance for anticipated dropouts and loss to follow-up, resulting in a final recruitment target of 146 participants (73 per group).\n\nRandomization and allocation:\n\nEligible participants who provide written informed consent will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened after baseline assessment. The study will use a single-blinded design in which the outcome assessor will remain unaware of the treatment allocation.\n\nIntervention group:\n\nParticipants allocated to the acetic acid group will receive 2% acetic acid ear drops, with 3 drops administered into the affected ear three times daily for one month.\n\nComparator group:\n\nParticipants allocated to the comparator group will receive 0.3% ciprofloxacin otic drops, with 3 drops administered into the affected ear three times daily for one month.\n\nFollow-up and assessment:\n\nParticipants will undergo clinical assessment at baseline and follow-up visits on the 7th, 14th, and 30th days. Otoscopic examination and otological symptom scoring will be performed to assess treatment response. Treatment compliance will be assessed through medication review, treatment diaries, and participant reporting.\n\nPrimary outcome:\n\nThe primary outcome is achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.\n\nSecondary outcomes:\n\nSecondary outcomes include reduction in ear discharge, improvement in otological symptoms such as otorrhea, ear discomfort and itching, treatment compliance and tolerability, recurrence or persistence of ear discharge, and adverse effects associated with treatment.\n\nData analysis:\n\nData will be entered and analyzed using SPSS version 26. Descriptive statistics will be reported with 95% confidence intervals. Continuous variables will be assessed for normality using the Shapiro-Wilk test. The Chi-square test will be used to compare treatment efficacy between the two groups, while Fisher's exact test will be used where appropriate. A p-value ≤0.05 will be considered statistically significant.\n\nExpected contribution:\n\nThe study aims to determine whether 2% acetic acid ear drops can provide an effective, safe, and potentially cost-efficient alternative to conventional topical ciprofloxacin therapy in the medical management of CSOM. The findings may contribute to evidence-based treatment of CSOM and help identify an accessible treatment option for patients.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"2% Acetic Acid Ear Drops","EXPERIMENTAL","Participants will receive 2% acetic acid ear drops, 3 drops in the affected ear three times daily for one month.",[49],"Drug: Acetic Acid 2% Ear Drops",{"label":51,"type":52,"description":53,"interventionNames":54},"0.3% Ciprofloxacin Ear Drops","ACTIVE_COMPARATOR","Participants will receive 0.3% ciprofloxacin ear drops, 3 drops in the affected ear three times daily for one month.",[55],"Drug: Ciprofloxacin 0.3% Otic Solution",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"DRUG","Acetic Acid 2% Ear Drops","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.",[45],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Ciprofloxacin 0.3% Otic Solution","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.",[51],[67],{"name":68,"role":69,"phone":70,"phoneExt":33,"email":71},"Asra Waseem, MBBS","CONTACT","+92 330 8174297","waseem.asra34@gmail.com",[73],{"facility":74,"status":33,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Dr. Ruth K. M. Pfau Civil Hospital Karachi","Karachi","Sindh","74200","Pakistan","PK",{"type":81,"coordinates":82},"Point",[83,84],67.0104,24.8608,{"lat":84,"lon":83},[87],{"name":88,"role":69,"phone":89,"phoneExt":33,"email":90},"DR. TEHMINA JUNAID","+92300 7048582","tehminajunaid12@gmail.com",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Dr. Asra Waseem","Principal Investigator","100657103","acetic-acid-ear-drops-versus-03--ciprofloxacin-for-chronic-suppurative-otitis-media-100657103",false,"NCT07835425","Acetic Acid Ear Drops Versus 0.3 % Ciprofloxacin for Chronic Suppurative Otitis Media.","Effectiveness of Acetic Acid Ear Drops Versus Standard Treatment in Medical Management of Chronic Suppurative Otitis Media","Inclusion Criteria:\n\n1. Age 18-70 years\n2. Either sex\n3. Persistent, non-foul-smelling ear discharge for ≥3 months\n4. Tubotympanic type chronic suppurative otitis media\n5. Baseline otological symptom score ≥5\n\nExclusion Criteria:\n\n1. Immunocompromised patients\n2. External auditory canal pathology\n3. Ear malignancy\n4. Known hypersensitivity to acetic acid or ciprofloxacin\n5. Pregnant women or lactating mothers","ALL","18 Years","70 Years",{"count":106,"type":107},146,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.",[113],"Otitis Media Chronic",[115],"CSOM ,ACETIC ACID DROPS","NOT_YET_RECRUITING","2026-09-20",{"date":119,"type":120},"2026-09-22","ACTUAL",{"date":122,"type":107},"2026-09-23",{"date":124,"type":107},"2027-01-18",{"name":5,"class":6},1]