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临床试验/CTRI/2025/07/091313
CTRI/2025/07/091313尚未招募4 期

Effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karnanada with special reference to Tinnitus a randomixed controlled clinical trial

Dr Ankita Sawant1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
98
试验地点
1
主要终点
To evaluate effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karna Nada w.s.r to Tinnitus

研究概览

简要总结

NEED FOR THE STUDY

Tinnitus is defined as a phantom auditory perception

Studies have reported highly variable tinnitus prevalence ranging from 4 percent to 37 percent worldwide

Mild sedative antidepressants vasodilators carbamazepine vitamins with anti oxidants have been tried with varying results  it can be treated by treating comorbidities such as hearing impairment  depression insomnia and anxiety

Tinnitus Retraining Therapy Counselling Sound therapy Tinnitus masker are some of the non pharmacological treatments used

In TRT tinnitus habituation is created

With this therapy patients suffering from tinnitus lose awareness of tinnitus and also do not get annoyed even when they do have tinnitus

TRT needs a long period of 18 to 24 months

The long term effect of TRT is not well known and outcome evaluation can take up to 1 to 2 years

A number of options have been used to treat patients with tinnitus but outcomes have been limited So ayurvedic approach will provide a turning point in the management of tinnitus as no absolute cure is there for tinnitus

Disease Review

KARNANADA

Acharya Sushruta has explained twenty eight types of Karna Rogas and KaranaNada is one of them

Vitiated vata dosha either entering into other channels or encircled by kaphadi doshas in sabdavaha srotas produces different types of sounds in the ear like bheri mrudanga shankha etc is known as Karna Nada

 The clinical features of Karna Nada relates to Tinnitus in modern science

TINNITUS

Tinnitus is an auditory sensation within the ears or head in the absence of any relevant external stimulus to cause it

It may vary in pitch and loudness and has been variously described by the patient as roaring hissing swishing rustling or clicking type of noise

Tinnitus is more annoying in quiet surroundings particularly at night when the masking effect of ambient noise from the environment is lost

TYPES OF TINNITUS

Two types of tinnitus are described

1 Subjective which can only be heard by the patient

2 Objective which can even be heard by the examiner

AIM

Effect of Swarjikadi Taila Karnapoorana and Sarivadi vati orally in Management of Karna Nada with special reference to Tinnitus

OBJECTIVES

Primary To evaluate Effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karna Nada with special reference to Tinnitus

SECONDARYTo compare the effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati with Apamarga Kshara Taila Karnapoorana and Sarivadi Vati in the management of Karna Nada with special reference to Tinnitus

RESEARCH QUESTION

Is Swarjikadi Taila Karnapoorana and Sarivadi Vati orally effective in the management of Karna Nada w.s.r to tinnitus when administered for period of 7 days

HYPOTHESIS

H0Swarjikadi Taila Karnapoorana and Sarivadi Vati orally is not comparable to Apamarga Kshara Taila Karnapoorana and Sarivadi Vati orally in the management of Karna Nada with special reference to tinnitus

H1  Swarjikadi Taila Karnapoorana and Sarivadi Vati orally is comparable to Apamarga Kshara Taila Karnapoorana and Sarivadi Vati orally in the management of Karna Nada with special reference to tinnitus

Expected Outcome

Swarjikadi Taila Karnapoorana and Sarivadi Vati orally if proved effective will help in reducing the symptoms of Karna Nada with special reference to Tinnitus

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Subjects presenting with sound in ear like bheri mrudanga shankha Roaring hissing swishing rustling or clicking type of noise Irrespective of socio economic status caste and religion will be taken Subjects who are fit for Karnapoorna.

排除标准

  • Congenital deformity of ear Daignosed cases of Aneurysm and arteriovenous shunt around the ear Blockage of external auditory canal due to wax or foreign body and perforation of tympanic membrane Daignosed cases of Intracranial vascular tumors and glomus tumors Cases of uncontrolled diabetes mellitus and hypertension Subjects not willing to be registered for the trial Subjects which required surgical intervention related with ENT.

结局指标

主要结局

To evaluate effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karna Nada w.s.r to Tinnitus

时间窗: DAY 0th(Before Treatment) | DAY 8th(After Treatment) | DAY 30th(Follow UP) | DAY 45th(Follow UP)

次要结局

  • To compare the effect of Swarjikadi Taila Karnapoorana & Sarivadi Vati with Apamarga Kshara Taila Karnapoorana & Sarivadi Vati in the management of Karna Nada w s r to Tinnitus(0th day)

研究者

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

Dr Ankita Sawant

KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre

研究点 (1)

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