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临床试验/CTRI/2019/07/020097
CTRI/2019/07/020097招募中2 期

A RANDOMIZED CLINICAL TRIAL ON COMPARATIVE EFFICACY OF PRIYANGVADI TAILA KARNAPICHU AND LAKSHADI AVCHURNAN ALONG WITH BHAIRAVA RASA ORALLY IN THE MANAGEMENT OF KARNASRAVA W.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月21日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
80
试验地点
1
主要终点
Change in the investigator assessment score for

研究概览

简要总结

In modern science management of chronic suppurative otitis media (CSOM) includesantibiotics, steroids and anti inflammatory drugs having adverse effects on prolonged usage and greater recurrence rate even after surgery. Thus thereis a need to search an effective, inexpensive and safe treatment in CSOM whichis applicable to all patients. Therefore Bhairav Rasa is selected which ishelpful in pratishyaya which is the the root cause of Karnasrava along with the local therapies in the form of  karnapichu and karna avachoornan to stop thedischarge and promote healing of the TM. Thus in this context the hypothesis is proposed that whether Priyangvadi Taila Karnapichu, Lakshadi Avachurnan and oraladministration of Bhairava Rasa are effective in the management ofKarnasrava (CSOM)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient having specific symptoms of Karnasrava.

排除标准

  • a)Pregnant women.
  • b)Patients with debilitating systemic diseases like Diabetes, Tuberculosis, Hypertension etc.
  • c)Patients having other aural pathologies like Otomycosis, Otitis externa, Furunculosis.
  • d)Patient having ear discharge complicated with haemorrhage, Cholesteotoma etc.
  • e)Patients suffering from any chronic debilitating disease, with other ear pathology and cases which required surgical intervention will be excluded from study.

结局指标

主要结局

Change in the investigator assessment score for

时间窗: 2 months 15 days

decrease in the quantity and consistency of ear discharge

时间窗: 2 months 15 days

次要结局

  • Any adverse event reported voluntarily,observed(or enquired)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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