“A randomized open labelled controlled clinical study to evaluate the efficacy of Bilva Taila Karnapoorana with Brahmi Ghrita orally in the management of Karnanada and Karnakshweda with special reference to Tinnitusâ€
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. karnanada (noise in the ear)
研究概览
简要总结
Karnanada is one among the Karna Rogas. Vata Dosha entering into Karna by Vimarga Gamana or encircled by Kaphadi Doshas (Sanga) in Sabdavaha Srotas, produces different types of sounds in the ear like that of Bheri (kettle drum), Mrudanga (a kind of drum), Shankha (conch shell) in Karnanada and Venughosha (flute like sound) in Karnakshweda. In contemporary science, the signs and symptoms of Karnanada and Karnakshweda can be correlated with Tinnitus. Tinnitus is characterized by the perception of sound in the absence of an external stimulus. Following a recent multidisciplinary consensus, tinnitus is termed as the conscious awareness of a tonal or composite noise for which there is no identifiable corresponding external acoustic source. The use of Sneha especially Taila helps to subside Vata Dosha and clears the Srotas of the Karna. Hence in the present study, an effort will be made to evaluate comparative efficacy of Bilva Taila Karnapoorana12 with Brahmi Ghrita13orally and Bilva Taila Karnapoorana with Ashwagandha Ghrita orally in the management of Karnanada and Karnakshweda with special reference to Tinnitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio- economic status and duration of illness.
- •Subjects having mild to moderate hearing loss.
- •Subjects who fulfill the diagnostic Criteria.
- •Subjects willing to participate in the study with written informed consent, which is conveyed in the language which the subject can understand.
- •Subjects with tinnitus who were not undergoing treatment for tinnitus in the last six months.
排除标准
- •Subjects having perforated tympanic membrane.
- •Subjects having any uncontrolled systemic illness which can interfere with the course of disease and treatment.
- •Subjects having congenital deformity of ear.
- •Subjects diagnosed with other diseases like tumors of ear, Aneurysms of carotid artery, Meningitis, Meniere’s disease, Acute suppurative otitis media and Chronic suppurative otitis media.
- •Subjects with hearing aids, hearing asymmetry or retro cochlear pathology, metabolic or psychiatric diseases.
- •Subjects’ incapable of filling/answering Tinnitus Handicap Inventory, Clinical Global Impression of Improvement (CGI-I) scale.
- •Pregnant and lactating women.
结局指标
主要结局
1. karnanada (noise in the ear)
时间窗: 1. 0th day – Pre- study Assessment | 2. 7th day – Assessment during trail period | 3. 30th day - Post study assessment | 4. 45th day – Drug free follow-up assessment.
2. karnapratinaha
时间窗: 1. 0th day – Pre- study Assessment | 2. 7th day – Assessment during trail period | 3. 30th day - Post study assessment | 4. 45th day – Drug free follow-up assessment.
3.Tinnitus handicap inventory,Tinnitus Handicap Inventory SEVERITY SCALE
时间窗: 1. 0th day – Pre- study Assessment | 2. 7th day – Assessment during trail period | 3. 30th day - Post study assessment | 4. 45th day – Drug free follow-up assessment.
4.Clinical Global Impression of Improvement (CGI-I)
时间窗: 1. 0th day – Pre- study Assessment | 2. 7th day – Assessment during trail period | 3. 30th day - Post study assessment | 4. 45th day – Drug free follow-up assessment.
次要结局
- Pure tone audiometry(Pure tone audiometry will be done on 0th day and 45th day.)