A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Nasya and Karnapoorana with Karpasasthyadi taila and Ksheerabala taila along with Ashwagandhadya ghritapana in Vataja badhirya w.s.r to Sensorineural Hearing loss.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Sensorineural hearing loss is a common condition that significantly affects communication and quality of life, and effective curative treatments are limited. Ayurveda describes a similar condition as Vataja Badhirya, for which procedures like Nasya, Karnapoorana, and Rasayana therapy are recommended.
This study is a randomized, open-label, comparative clinical trial designed to evaluate and compare the effectiveness of two Ayurvedic treatment protocols in patients with mild to moderate sensorineural hearing loss. Sixty eligible participants will be randomly allocated into two groups. One group will receive Nasya and Karnapoorana with Karpasasthyadi Taila along with Ashwagandhadya Ghritapana, while the other group will receive Nasya and Karnapoorana with Panchavalkala Taila along with Ashwagandhadya Ghritapana.
The treatment will be administered for 30 days, with a follow-up period of 15 days. The primary outcome will be assessed by changes in hearing thresholds measured using pure tone audiometry. Secondary outcomes will include improvement in tinnitus, vertigo, and quality of life assessed using appropriate grading scales and questionnaires.
The study aims to generate clinical evidence regarding the role of Ayurvedic therapies in the management of sensorineural hearing loss.
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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to participate in the study 2.Patients having specific signs and symptoms of Badhirya (SNHL) as per Ayurvedic and modern parameters will be registered Ayurvedic symptom : Hearing difficulty without discharge ,with or without associated with karnanada and bhrama, Modern:Hearing loss with or without tinnitus and vertigo.
- •3.Pure tone audiometry findings(sensorineural pattern),and supportive tuning fork tests(Rinne positive,Weber lateralised to better ear) 4.Patients having mild to moderate hearing loss(26-55db) in the better ear as per WHO grading.
- •5.Patients in the age group of 40-70 years.
排除标准
- •1.Patients having any congenital hearing loss.
- •2.Individuals of SNHL secondary to other diseases like carcinoma, Meniere’s disease, otosclerosis.
- •3.Uncontrolled diabetes mellitus and hypertension.
- •4.Perforated TM.
- •5.Pregnant women.
- •6.Psychogenic hearing loss.
- •7.History of intake of ototoxic drugs.
- •8.Infectious diseases such as measles, meningitis, or any TORCH infection.
- •9.Hyperlipidaemia.
研究者
DrNimisha K
National Institute of Ayurveda