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临床试验/CTRI/2023/05/052945
CTRI/2023/05/052945尚未招募2/3 期

A Randomized Comparative Clinical study to evaluate the effect of Nirgundyadi Tail karnapoorna and Hingvadi Tail karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus)

Dr Akshay Garg1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in subjective and objective criteria of Karnanada

研究概览

简要总结

Tinnitus is a common problem for millions of people, as epidemiological studies have reported its prevalence to be between 8 to 25.3% of the population of the United States.Similarly, population based studies conducted in other nations have found a similar prevalence of Tinnitus, ranging from 4.6% to 30%.Tinnitus is a common and debilitating disorder in India with a prevalence of more than 7% of the Indian population.It severely affects the quality of life of around 1-3% of the world.Tinnitus affects 10 to 15 % of adult general population. About 20 % of Tinnitus population requires serious clinical .The 7th – 13th of February 2022 brings us Tinnitus Awareness Week Recognized each year throughout the world in the first full week of February, the purpose of this week is to educate the public about the symptoms of tinnitus and how it affects people.The prevalence of tinnitus increases to 70-85% in the hearing-impaired population.

Available treatments for the management of Tinnitus are diverse. Highest evidence for clinical efficacy is available for cognitive-Behavioral therapies. Further established treatment includes counselling and various forms of sound therapy along with methods that attempt to increase input to the auditory system, such as hearing aids and masking of Tinnitus, Sedation and Tranquilizers.Despite its prevalence and effect on quality of life there is no evidence based guideline about management of Tinnitus till today and hence poses a challenge for finding such drugs or therapies in alternate systems of medicine.Ayurveda has a systematic line of treatment in the management of Karnanada. The Line of treatment in Ayurveda for four diseases viz. Karnashoola, Pranada, Karnashweda and Badhirya is similar. The General line of Treatment for Karnarogas is Ghritapana , Rasayana, Avyayama, Ashirasnana, Brahmacharya, AkathanaKarna is one of the Adhisthana of Vata Dosha..In Ayurveda since vata is the main dosha involved in karnanada disease. The treatment should be aimed at Vatashamana and Rasayana Karnapooran is an important therapy in karnarogas.It has unique quality of getting absorbed easily by the pores in the skin and there by act to supply the nutrition to nerves.Hence in present study, Karanpoorna with Nirgundyadi Tail and Hingvadi Tail possessing vatahara property is selected for the study. Ghrita is having“Sanskarasya  Anuvartanatva so Ashwagandha Ghrita is selected for internal administration having Rasayana,Balya and Vatahara properties which can prevent age related degenerative changes in the inner ear.Hence it is proposed to undertake this study entitled "A Randomized Comparative Clinical Study to Evaluate the Effect of Nirgundyadi Tail Karnapoorna and Hingvadi Tail Karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus)"

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Patients between age of 16-60 years irrespective of age, sex, caste, religion etc.
  • 2.Patients will selected on the basis of signs and symptoms of Karnanada (Tinnitus).
  • 3.Subjective type of tinnitus.
  • 4.Patients willing to be registered for trial.

排除标准

  • 1.Patients of age <16 years and >60 years 2.Patients suffering from any chronic debilitating disease like DM, HTN, KOCH’S and with other ear pathologies.
  • 3.Objective type of Tinnitus.
  • 4.Cases of tinnitus which required surgical intervention.
  • 5.CSOM,Otomycosis,Perforated TM.
  • 6.Pregnant, Immune compromised patients 7.Tinnitus associated with disease like – any growth of middle ear, Aneurysms of carotid artery, palatal myoclonus, and meningitis.
  • 8.Degree of hearing loss greater than 40 dB.
  • 9.Paitents not willing to be registered for trial.

结局指标

主要结局

Change in subjective and objective criteria of Karnanada

时间窗: 90 Days

次要结局

  • 1)To study the Karananada from various ayurvedic texts.(2)To study the Tinnitus from modern texts.)

研究者

发起方
Dr Akshay Garg
申办方类型
Other [self]

研究点 (1)

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