Study of Ayurveda Therapies in Badhirya with Special Reference to Noise Induced Hearing Loss.

Phase 2

Not yet recruiting

Conditions: Noise effects on inner ear. Ayurveda Condition: BADHIRYAM,

Registration Number: CTRI/2023/12/060696

Lead Sponsor: National Institute of Ayurveda

Brief Summary: Hearing impairment reduces the quality of life, nowadays over exposure to noise is responsible for 16% of hearing loss in adults globally(over 4 million DALYs).Noise -induced hearing loss (NIHL) is used to describe that hearing loss which is of sensorineural type and develops after exposure to hazardous noise levels (>85%), usually affects both ears equally in extent and degree.This type of hearing loss may be temporary and described as temporary threshold shifts (TTS) which lasts from hours to days and can be regained within 16 hours to 48 hours. It may be permanent and described as permanent threshold shift (PTS) which can arise after a single episode of noise exposure. PTS shifts are divided into Acoustic trauma and Noise included hearing loss. Acoustic trauma results from single exposure to an intense sound and leads to an immediate hearing loss. NIHL depends on the intensity, frequency and duration of the noise exposure. The pure tone audiometry shows characteristic notch with maximum reduction in sensitivity to stimulation in the range from 3 to 6 kHz and recovery at 8 kHz. NIHL results from loss of structural hair cell function. NIHL associated with other causes of hearing loss may not be present with the characteristic 4kHz notch. Absence of the notch does not excluded noise induced hearing loss.Pure tone audiometry is the corner stone of investigation to find out the noise induced hearing loss. In Ayurveda, Hearing loss can be incorporated under *Badhirya*, among the twenty eight *Karna rogas*. In *Uttara Tantra*, *Acharya Sushruta* mentioned that when vitiated *vata dosha* along with *kapha* resides in *Shabdanuvaha sira* and in the absence of appropriate treatment the person will suffer from *Badhirya* without any doubt.In *Nidaansthan, Acharya Sushruta* has explained that the either *kevala vayu* or *kaphaanubandha vata* initiates the pathology of *Badhirya* by obstructing the *Shabdavaha srotas*. The common etiological factors of *Karnaroga* are *Avasyaya*, *Jalakrida*, *Karnakandu*, *Mithya yogensastra* and *Pratishyaya*. In *Uttar sthana Acharya Vagbhata* mentioned *â€˜Mithyayogena Shabdasyaâ€™* as causative factor for *karnaroga*. *Badhirya* is mainly caused by *Srotorodha* due to predominance of *vata* or *vata kapha dosha*. In noise induced Hearing loss, *Mithyayogena Shabdasya* may be considered as a prime factor as loud intensity of sound is the main precursor for NIHL. *Acharya Sushruta* described general line of treatment for *Karnarogas* which comprises of *Ghrita Pana*, *Rasayana sevana*, *Avyayam*, avoid head bath and abstaining from excessive talking and celibacy.

NEED OF THE STUDY:Noise-induced hearing loss, which is damage to the stereocilia caused by exposure to loud levels of noise, is the second most common cause of sensory neural hearing loss. The World health Organization (WHO) estimates that billions of people widely are at continued risk of NIHL due to exposure to loud sound levels. Studies shows that one-third of all cases of hearing loss can be attributed to noise exposure. An estimated 12.5% of children and adolescents aged 6-19 years (approx. 5.2 million) and 17% of adults aged 20-69 years (approx. 26 million) have suffered permanent hearing impairment from excessive exposure to noise pollution.Worldwide, studies have found that workers engaged in construction, industrial (metal, textile etc), firefighters, military, civil aviation, railways, agriculture, traffic policemen, teachers etc at increased risk of NIHL.This data represent NIHL a serious health problem. Loud intensity of Noise damages our hearing by destroying the microscopic hair cells in the inner ear which help in conveying sound to the auditory nerve and the brain where the sound is processed. Millions of people are suffering from noise-induced hearing loss (NIHL), resulting in a reduced quality of life due to social isolation and possible inexorable tinnitus, as well as communication problems with family members, co-workers, and friends. In present scenario, there is no proper treatment to combat NIHL, hence Methyl Prednisolone is given in tapering dose but without much result. Avoidance measures like public awareness, education, physical barriers to noise do not seem to be suffice this problem as the population is still being affected by damaging noise levels. Therefore it is necessary to develop safe, effective and affordable treatment modalities which may diminish or prevent the impact of noise induced hearing loss.

There are very limited studies in India on NIHL and no such research work has been conducted on NIHL in any Ayurvedic institution so far and this condition is also effecting younger generation greatly after covid due to increased usage of headphones.

Hence the current study, entitled â€˜Randomized controlled trial on efficacy of Ayurveda Therapies in *Badhirya* w.s.r. to Noise Induced Hearing Lossâ€™ is planned in order to give some relief to the above patients. In present study, one group will be treated on Ayurveda treatment Modalities comprising of Local therapies *Nasya*, *Karnapoorana*, *Shiropichu* along with internal medications like *Brahmi Ghrita pana* and *Brahmi Vati*. *Ksheerabala Avartana Taila* will be used for *Nasya* and *Karnapoorana* and plain *Ksheera Bala Taila* will be used for *Shiropichu*. *Ksheerabala* is one of the proven nervine tonic which is essential in NIHL. *Snehapana* is considered to be an ideal therapy which acts as *Rasayana* in all *Karna rogas*. The other group will be treated with conventional treatment comprising of short term course of Methyl Prednisolone. This is no such proven result with this treatment but it reduces the nerve inflammation to some extent.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Patients with history of exposure to Noise.
(NIOSH & OSHA10) 2.Patients with history of prolonged usage of listening devices (headphones, transceiver etc).
3.Patient with signs and symptoms of Badhirya due to Noise Induced Hearing Loss (NIHL).
4.Patients between the age group of 18 to 70 years.
5.Patients willing to give written consent.

Exclusion Criteria

1.Patients with hearing Loss due to other causes.
2.Patients on ototoxic drugs, head injury, any other major exanthematous illness.
3.Patients having tympanic membrane perforation.
4.Patients with previous ear surgeries, congenital malformations etc.
5.Patients who are contraindicated for Methyl prednisolone.
6.Patients with presbycusis.
7.Patients with hypertension and diabetes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in PTA (Audiogram).	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Changesin Effect on Quality of Life (life geneâ€™s questionnaire).

Trial Locations

Locations (1): National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
dr satyavati
Principal investigator
07618281746
drsatyadagar@gmail.com