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临床试验/CTRI/2024/10/075407
CTRI/2024/10/075407尚未招募2 期

A Comparative Clinical Study To Evaluate The Efficacy Of Karnavatahara Taila Karnapoorana And Ksheerabala Taila Karnapoorana In The Management Of Karnanada

Dr Shreya Kamat1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月27日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1) Tinnitus Severity Index Questionnaire-based Score

研究概览

简要总结

NEED FOR THE STUDY

Karnanada is one of the karnagata rogas mentioned by Acharya Sushruta. Hearing different types of sounds in the ear in the absence of external stimulus is the main symptom of karnanada. According to Acharya Sushruta, karnasthita vayu becomes vimargagami and takes ashraya in shabdavaha srotas, producing different types of sounds, known as karnanada.

The lakshanas of karnanada can be correlated to the symptoms of Tinnitus. Tinnitus is an auditory sensation within the ears in the absence of any relevant external stimulus to cause it.

15% to 20% of the global population suffers from some form of tinnitus according to CDC. According to a study conducted by Department of Audiology, All India Institute of Speech and Hearing, Mysore, the prevalence of tinnitus was found to be 6.7% among the Indian adult population.

Tinnitus-induced annoyance, tension and insomnia have a significant negative influence on the quality of life and mental health. It can disrupt sleep and cause communication issues, anxiety, irritability, concentration difficulties or depression. In extreme cases, some patients have suicidal thoughts or actions.

There are no effective medicines to treat tinnitus according to conventional systems of medicine. The modes of treatment include prescribing sedatives and tranquilizers, psychotherapy and masking of tinnitus using tinnitus maskers.

According to Acharya Sushruta, Vatahara line of treatment is applicable to treat karnanada-snigdha virechana with vatahara dravyas, nadi sweda, pinda sweda. Karnapoorana is a type of Pravicharana snehana and swedana.

Hence the study has been taken with Karnavatahara taila karnapoorana mentioned in Basavarajeeyam, Ksheerabala taila karnapoorana mentioned in Ashtanga Hrudaya which is safe, devoid of complications, cost effective.

 HYPOTHESIS:

Null hypothesis

H0- Karnavatahara taila Karnapoorana and Ksheerabala taila Karnapoorana have no significant effect on Karnanada.

 Alternate hypothesis

H1- Karnavatahara taila Karnapoorana is having better effect than Ksheerabala taila Karnapoorana in Karnanada.

H2- Ksheerabala taila Karnapoorana is having better effect than Karnavatahara taila Karnapoorana in Karnanada.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with symptoms of Karnanada irrespective of sex, occupation, religious & social status.
  • Patients in the age group of 18 to 70 years with intact tympanic membrane.
  • Patients with score of 1-18 in Tinnitus Severity Index Questionnaire will be included in the study.

排除标准

  • Objective tinnitus
  • Tinnitus associated with hearing loss, Congenital deformity.
  • Blockage due to stenosis of External auditory canal / wax.
  • Tinnitus due to anemia, diabetes, hypertension, thyroid disorders, glomus tumor etc.

结局指标

主要结局

1) Tinnitus Severity Index Questionnaire-based Score

时间窗: 51 days

次要结局

  • Ringing sound in the ear(51 days)

研究者

发起方
Dr Shreya Kamat
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shreya Kamat

Govt Ayurveda Medical College, Bengaluru

研究点 (1)

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