Effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karnanada with special reference to Tinnitus a randomixed controlled clinical trial
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
Dr Ankita Sawant
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre
