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CTRI Number  CTRI/2023/12/060696 [Registered on: 22/12/2023] Trial Registered Prospectively
Last Modified On: 30/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of Ayurveda Therapies in Badhirya with Special Reference to Noise Induced Hearing Loss.  
Scientific Title of Study   Randomized Controlled Trial on Efficacy of Ayurveda Therapies in Badhirya With Special Reference to Noise Induced Hearing Loss. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satyavati 
Designation  Ph.D Scholar  
Affiliation  Phd Scholar 
Address  Room no 306 3rd floor Academic building Dept of Shalakya Tantra National Institute of Ayurveda ,Jaipur
VPO- Ghasola, Tehsil & District Charkhi Dadri, Haryana. PIN 127306
Bhiwani
HARYANA
127306
India 
Phone  07618281746  
Fax    
Email  drsatyadagar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Shamsa Fiaz  
Designation  Professor and H.O.D  
Affiliation  Professor and H.O.D  
Address  Room no 309 Department of Shalakya Tantra National Institute of Ayurveda, Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Villa No.9,Pearl The Nest, Ramnagariya, JDA Scheme, Jaipur.
Jaipur
RAJASTHAN
302002
India 
Phone  8764009846  
Fax    
Email  shamsa_fiaz@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Shamsa Fiaz  
Designation  Professor and H.O.D  
Affiliation  Professor and H.O.D  
Address  Room no 309 Department of Shalakya Tantra National Institute of Ayurveda, Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan
Villa No.9,Pearl The Nest, Ramnagariya, JDA Scheme, Jaipur.
Jaipur
RAJASTHAN
302002
India 
Phone  8764009846  
Fax    
Email  shamsa_fiaz@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be University (De-novo)  
 
Primary Sponsor  
Name  National Institute of Ayurveda  
Address  National Institute of Ayurveda, Deemed to be University (De-novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr satyavati   National Institute of Ayurveda  OPD No.13, National Institute of Ayurveda, Deemed to be University(De-novo), Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002
Jaipur
RAJASTHAN 
07618281746

drsatyadagar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H833||Noise effects on inner ear. Ayurveda Condition: BADHIRYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-karNapUraNam, कर्णपूरणम् (Procedure Reference: Sushruta Samhita and Procedure Drug Reference Sahasrayoga , Procedure details: 1. Nasya & Karnapoorana with Ksheera Bala Avartana Taila - Three sittings of Nasya & Karnapoorana (Each of seven days duration) with five days gap in between sittings. 2. Shiropichu with Ksheera Bala Taila- Three sitting of Shiropichu duration of Seven days with Five days gap in between sittings ).)
(1) Medicine Name: Brahmi vati, Reference: Ayurveda Sara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 375(mg), Frequency: bd, Duration: 30 Days
(2) Medicine Name: Brahmi Ghrita, Reference: Astanga Hridayan, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Duration: 10 Days
2Comparator Arm (Non Ayurveda)-Tab Methyl Prednisolone30 patients will be treated with Methyl Prednisolone for 30 days and gradually tapered dose of 2mg from 64mg of initial dose
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in PTA (Audiogram).  8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Effect on Quality of Life (life gene’s questionnaire).
 
8 Weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 ‘Mithyayogena Shabdasya’ 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 ‘Randomized controlled trial on efficacy of Ayurveda Therapies in Badhirya w.s.r. to Noise Induced Hearing Loss’ 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.


 
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