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临床试验/CTRI/2020/06/025721
CTRI/2020/06/025721尚未招募2 期

A Randomised Open Label Comparative Clinical Study To Evaluate The Efficacy Of ASHWAGANDHA GHRITA Orally And KSHEERA BALA 101 TAILA NASYA In The Management Of BADHIRYA W.S.R TO Sensorineural hearing loss

Dr Pooja Gopalani1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月8日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
improvement in hearing ability and it will be measured by pure tone audiometry

研究概览

简要总结

Hearing loss is the second most common cause of disability in India , 63 million people suffer from the significant auditory loss and is  more common in the age group of 40 - 60 years . The patient to Sensorineural Hearing Loss is managed by corticosteriods , hearing  aids or cochlear implants , the above treatments help the patient to improve their conditions temporarily . In accordance to Hearing Loss , Badhirya has been mentioned in Ayurveda and the Chikitsa mentioned is Vataghna and Vata- kaphagna . Thus considering the above facts , the line of treatment i.e Rasayana and Nasya mentioned in Badhirya has been taken up for the study . Hence , Ksheerabala 101 Taila Nasya has been indicated which would pacify the aggrevated vata dosha  and ashwagandha ghrita given orally has Rasayana  properties .

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

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

入选标准

  • •1.Subjects with Sensorineural Hearing Loss.
  • •2.Subjects with Intact Ear Drum.
  • •3.Subjects in the age group 40-60 years.

排除标准

  • •1Subjects associated with Tympanic Membrane Perforation.
  • •2Subjects of Congenital Hearing Loss.
  • •3Subjects with Conductive Hearing Loss and Mixed Hearing loss.
  • •4Subjects with Otorrhoea.
  • •5Subjects that are contra-indicated for Nasya.

结局指标

主要结局

improvement in hearing ability and it will be measured by pure tone audiometry

时间窗: 30 days

次要结局

  • improvement in hearing will be measured by NRS scale for deafness and the tuning fork tests which are rinnes test, webers test and ABC test(30 days)

研究者

发起方
Dr Pooja Gopalani
申办方类型
Other [self]

研究点 (1)

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