跳至主要内容
临床试验/CTRI/2025/11/097981
CTRI/2025/11/097981尚未招募2/3 期

A Single Arm Clinical Study to evaluate the efficacy of Narayana Taila Matra Basti and Musali-Bakuci Churna along with Urdhwajatrugata Abhyanga in the management of Badhirya (Sensori-Neural Hearing Loss)”

Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月2日最近更新:

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
Reduction in scoring pattern of sign and symptoms of Badhirya (Sensorineural Hearing Loss)

研究概览

简要总结

In Sense organs are essential for human life, allowing us to perceive and interact with our surroundings. Any disruption in their function can lead to significant challenges. Hearing impairment is one of the most common sensory disabilities, affecting millions of people worldwide. It can hinder the ability to perceive speech, leading to communication difficulties, delayed language development, social isolation, stigmatization, and disadvantages in both education and employment. Ayurveda, the term ‘Badha’ means obstruction, and ‘Badhirya’ refers to the condition that obstructs hearing. Acharya Sushruta classified Badhirya as one of the 28 Karnarogas (ear diseases). He explained that when the Vata and Kapha doshas become vitiated and accumulate in the Siras, they affect the Shabdanuvaha Siras (auditory nerve) in the Shrotrendriya (organ of hearing). This leads to Srotorodha (blockage of the auditory channels), and if left untreated, results in Badhirya . Similarly, Acharya Vagbhata described Badhirya as being caused by vitiated Vayu along with Kapha, particularly when early signs like Karnanada (ringing in the ears) are ignored . Hearing impairment is defined as the partial or complete loss of hearing in one or both ears. Its clinical symptoms closely align with the condition known as Badhirya in Ayurveda and may be either present at birth (congenital) or develop later in life (acquired).  In modern medicine, hearing loss is generally classified into three types : 1.Conductive, 2.Sensori-neural,3.Mixed. Conductive hearing loss (CHL) occurs due to an obstruction in the transmission of sound from the external ear to the stapediovestibular joint. Sensori-Neural hearing loss (SNHL) results from damage to the cochlea, the vestibulocochlear nerve, or related central pathways. Mixed hearing loss includes elements of both conductive and Sensori-neural types. Hearing loss affects one’s quality of life depending on the severity of hearing loss. Hearing aids, implants, and assistive devices are most common instrumental devices which are used in rehabilitation of the impaired hearing. Despite their success, hearing aids and cochlear implants are not perfect in all situations.  In more severe cases where conventional hearing aids are inadequate, cochlear implants may be considered. Despite these options, the high cost of modern treatments often makes them inaccessible for the average person in India. Ayurvedic treatment presents a potentially affordable and effective alternative. Therefore, this study seeks to evaluate the use of Ayurvedic therapies as a cost-efficient and safe approach for managing hearing impairment. Being a complete medical science, Ayurveda possesses many wonders, which are still beyond our site & understanding. Hence, to find out such phenomenon of Ayurveda, Badhirya (SNHL) has been selected for the present study. Narayana Taila Basti is described in classical texts for Badhirya and Musali-Bakuci Churna mixed in equal quantity along with Madhu is also described in classical ayurvedic texts for Badhirya. With the administration of Snehana dravyas, the Vayu is eliminated & Mridutva in the body is produced. The vitiated Doshas, which obstructs the srotas, are eliminated with the help of snehana.By employing a randomized open-label clinical trial design, this research aims to generate scientific evidence for the effectiveness of Narayana Taila Matra Basti along with MusaliBakuci Churna orally potentially establishing it as a viable, natural alternative to modern pharmacotherapy.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

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 having signs and symptoms of Badhirya (SNHL) with mild (26-40 dB), moderate (41-55 dB) and moderately severe (56-70dB) hearing loss will be selected.
  • Patients having sign and symptoms of Badhirya (SNHL) persisting upto less than 1 year.
  • Patients having associated symptoms of Badhirya i.e. Karnanada.
  • The patient is willing and able to participate in the study.

排除标准

  • Patients with congenital hearing loss and age above 60 years.
  • Patients with a profound degree of hearing impairment (greater than 70 dB).
  • Patients having symptoms of Badhirya (SNHL) persisting for more than 12 months.
  • Patients with Otorrhoea.
  • Conductive & mixed hearing loss.
  • Pregnant women
  • Patients who require otological surgical intervention.
  • Malignancy related to the external, middle, and internal ear.
  • Patients with systemic illnesses like DM, Hypertension, Tuberculosis…etc.

结局指标

主要结局

Reduction in scoring pattern of sign and symptoms of Badhirya (Sensorineural Hearing Loss)

时间窗: Reduction in scoring pattern of sign and symptoms of Badhirya (Sensorineural Hearing Loss)

次要结局

  • Improvement in associated symptoms of Badhirya i.e karnanada(Improvement in Quality of Life by a validated questionare (QOL))

研究者

发起方
Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nitika

INSTITUTE FOR AYURVED STUDIES AND RESEARCH

研究点 (1)

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