A Randomized Open Labelled Comparative Clinical Study toEvaluate the Efficacy of Madhukadi Tail Karnapoorna and Apamargkshar TailKarnapoorna along with Goghrita orally in the Management of Karnanada(Tinnitus)
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
- Improvement in karnanada symptoms and objective parameters like masking test for tinnitus and audiometry
研究概览
简要总结
As epidemiological studies have shown, tinnitus is a common problem for millions of people reports its prevalence to be between 8 and 25.3% of the United States population. Similar findings were made by population studies conducted in other countries prevalence of tinnitus ranging from 4.6% to 30%. This disorder in India is with a prevalence of more than 7% of the Indian population. It is serious, it affects the quality of life of about 1-3% of the world. Tinnitus affects 10 to 15% of adults’ general population. About 20% of the tinnitus population requires serious clinical. Tinnitus Awareness Week was between 5 and 11 February 2024. Aim of this campaign was to educate and raise awareness of tinnitus, provide support to those affected and promote research into effective treatment. The treatments available for tinnitus are varied. The ultimate proof for clinical efficacy is available for cognitive- behavioral therapies. Further established treatment includes counseling and various forms of sound therapy along with methods that attempt to increase input to the auditory system such as hearing aids and masking Tinnitus, sedation and tranquilizers. Despite its prevalence and impact on quality of life there are no evidence- based guidelines for the treatment of tinnitus to date, and therefore presents a challenge to find such drugs or therapies in alternative systems of medicine. Ayurveda has a systematic line of treatment under the management of Karnanada. Line from 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, Akathana. Karna is one of the Adhisthana Vata Dosha. In Ayurveda, vata is the main one dosha involved in Karnad disease. Treatment should be directed at Vatashaman and Rasayan Karnapooran which is an important therapy in karnarogas. It has a unique the quality is easily absorbed by the pores in the skin and acts on the supply their nutrition for the nerves. Therefore, in this study, Karanpoorna with Madhukadi tail and Apamargkshar Tail possessing vatahara property is selected for the study. Administration of Goghrita orally pacifies Vata and improves the strength of the nerves, it has Rasayana, Balya and Vatahara properties which can prevent age related degenerative changes in the internal ear. Hence it is proposed to undertake this study entitled “A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Madhukadi Tail
Karnapoorna and Apamargkshar Tail Karnapoorna along with Goghrita orally in the
management of Karnanada (Tinnitus)”.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients between the age of 16-60 years irrespective of age, sex, caste, religion etc.
- •Patients will be selected based on symptoms of Karnanada (Tinnitus).
- •Subjective type of tinnitus.
- •Tinnitus without vertigo.
排除标准
- •Patients of age less than 16 years and more than 60 years
- •Patients suffering from any chronic debilitating disease like DM, HTN, KOCH’S and with other ear pathologies.
- •Objective type of Tinnitus.
- •Cases of tinnitus which required surgical intervention.
- •CSOM, Otomycosis, Perforated TM.
- •Pregnant and Immuno-compromised patients
- •Tinnitus associated with disease like – any growth of middle ear, Aneurysms of the carotid artery, palatal myoclonus, Meniere’s disease and meningitis.
- •Drug induced tinnitus e.g. high dose aspirin, ibuprofen, diclofenac etc.
结局指标
主要结局
Improvement in karnanada symptoms and objective parameters like masking test for tinnitus and audiometry
时间窗: 60 days
次要结局
- Quality of life will be improved. Decrease in Tinnitus Handicap Inventory score Improvement in mild hearing loss(60 days)
