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临床试验/CTRI/2023/06/054025
CTRI/2023/06/054025尚未招募2/3 期

Efficacy of an Ayurvedic Intervention on Chronic Suppurative Otitis Media

Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年6月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Discharge quality and quantity

研究概览

简要总结

The patient diagnosed with Chronic suppurative otitis media fulfilling inclusion and exclusion criteria attending OPD Shalakya tantra and ENT OPD, S.S.Hospital ,IMS, BHU will be assigned into study group and trial group stratified block randomised 6 patient in 1 block with strata of discharge mild, moderate and severe.Each group comprises 100 patients. Study group will receive Sarivadi vati (500mg) 2 tablet bd,after food upto 1 month and dry mopping and Karnadhoopana yoga 5-10 gm for 7 days and control group will receive aural toileting with vinegar (1ml) and normal saline(1ml) for 5 days , local antibiotic ciprofloxacin 2 drops bd  for 5 days. The study will be interventional, comparative RCT. The patients will be assessed based on subjective and objective parameters and follow up for consecutive 2 months in an interval of one month. Subjective parameters will be assessed according to scores -Otorrhea/Ear discharge -quality/quantity, Hearing loss,Tinnitus, Just before commencing treatment, after treatment and during follow up. Objective parameters include Perforation of Tympanic membrane, Pure Tone Audiometry and culture sensitivity test, assessed on before treatment and after treatment. The data collected will be analysed statistically by using appropriate test.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients Suffering from Safe or Tubo-Tympanic Chronic Suppurative Otitis Media without complications Chronicity of the CSOM more than 3 months Patients ready to sign informed consent form.

排除标准

  • Patients Suffering from Unsafe or Attico-antral Chronic Suppurative Otitis Media Chronicity of CSOM less than 3 months CSOM with systemic complications CSOM with serosanguinous discharge CSOM with Sensori-nueral and mixed hearing loss.

结局指标

主要结局

Discharge quality and quantity

时间窗: Day 0,Day7, Day15,Day30, Day45, Day 60

次要结局

  • Changes in Perforation of TM,(Culture and Sensitivity and)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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