CTRI/2024/03/064148尚未招募4 期
Comparison of efficacy and safety of Amoxicillin-clavulanic acid versus ciprofloxacin in patient of active stage of tubotympanic type of chronic suppurative otitis media in a tertiary care hospital - a prospective, randomized, Open-label study
Indira Gandhi Government medical college and Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年4月1日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Proportion of patients showing complete stoppage of otorrhea at the end of 2 weeks
研究概览
简要总结
This is a prospective, randomized, controlled clinical open-labelled study. The study was approved by the Institutional Ethics committee and will be done according to the ICMR guidelines for Biomedical Research on Human subjects, 2006 and the Declaration of Helsinki. Subjects were recruited in the ENT outpatient Department of a tertiary care teaching hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants to be attending the outpatient clinic in the department of ENT,
- •Adults of either sex, greater than 18 years
- •Clinically documented or New cases of a tubo-tympanic variety of CSOM with clinical signs & symptoms of the disease and baseline otological symptom score of >4 but ≤ 8 were included in the study12
- •Patients willing to participate in the study by giving Informed consent
- •Outpatient department.
排除标准
- •Atticoantral type of chronic suppurative otitis media
- •Age less than 18 years
- •Impending complications
- •Patients with acute otitis media and all physical and other subtypes of otitis media, such as otitis media with effusion.
- •Otomycosis
- •Severe cases of CSOM for which hospitalization or parenteral antibiotic treatment is required and patients with otological symptom score of ≤4 and >8 were also excluded from the study
- •Patients with foul-smelling Ear discharge
- •Large aural polyp in the middle ear
- •Patients who, received antibiotics either topical or systemic in the preceding 4 weeks of screening 10.Otological surgery within the past year
- •Presence of tympanostomy tube
- •Acute traumatic perforation
- •Symptomatic conditions such as otitis externa, chronic sinusitis, chronic pharyngitis requiring systemic antibiotic therapy that could interfere with the evaluation of study drugs
- •History of allergies to the study medication
- •Acute serious illness (like Myocardial Infarction, Stroke, Sepsis, Electrolyte disturbances)
- •Known case of any malignancy
- •Known case of any liver and kidney disease 18.Pregnant women and lactating mothers
- •Patients in Inpatient department
- •Underlying chronic diseases such as Diabetes mellitus, Tuberculosis
- •Known case of immunodeficiency.
结局指标
主要结局
Proportion of patients showing complete stoppage of otorrhea at the end of 2 weeks
时间窗: reduction of otorrhea after 3 days, 1 week and 2 weeks
次要结局
- Ear discharge must be sterile or no pus after completion of course of treatment
- Recording of adverse event, if any, according to the prescribed proforma issued by(Pharmacovigilance program of India (PvPI).)
- Analyzing the cost-effective analysis of antimicrobials(cost effective analysis will be done at day 0 , day 3 , day7 and day 14)
研究者
SRIRAMAGIRI SAI VINAY
Indira Gandhi Government medical college and Hospital
研究点 (1)
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