| CTRI Number |
CTRI/2025/11/097981 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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) |
|
Scientific Title of Study
|
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)” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitika |
| Designation |
P.G. Scholar |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room No 108
PG Department of Shalakya Tantra
Institute For Ayurved Studies And Research, Umri Road, Sector 8,
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8398963449 |
| Fax |
|
| Email |
nitihooda83989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu |
| Designation |
Professor, Department of Shalakya Tantra |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room No 108
PG Department of Shalakya Tantra
Institute For Ayurved Studies And Research, Umri Road, Sector 8,
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashu |
| Designation |
Professor, Department of Shalakya Tantra |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room No 108
PG Department of Shalakya Tantra
Institute For Ayurved Studies And Research, Umri Road, Sector 8,
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra pin
136118, Haryana, India
|
|
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Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra |
| Address |
Umri road, sector 8, Kurukshetra
Pin
136118, Haryana, India
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitika |
Institute for Ayurved Studies and Research |
Room no 50, PG Department of Shalakya Tantra Institute for
Ayurved Studies and Research Umri
road sector 8
KURUKSHETRA
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
8398963449
nitihooda83989@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H905||Unspecified sensorineural hearingloss. Ayurveda Condition: BADHIRYAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Bhaishajya Ratnavali with Vidyotani Hindi commentary. Vatavyadhi Chikitsa, Chapter 26/330–337, Procedure details: y. Study of Matra Basti will be completed in 2 cycles of
14-14 days with a gap period of 14 days in between. In this gap period Urdhwajatrugata
Abhyanga with Tila Taila will be done and Musali- Bakuci Churna will be given orally
continuously for 56 days of study. )
(1) Medicine Name: musali bakuci churna, Reference: Rasa Ratna Samuchchya. 9th ed. Edited by Shastri A. Shloka 24/12, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 56 Days(2) Medicine Name: narayana taila, Reference: Bhaishajya Ratnavali with Vidyotani Hindi commentary. Vatavyadhi Chikitsa, Chapter 26/330–337, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 28 Days |
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
Patients with congenital hearing loss and age above 60 years.
2. Patients with a profound degree of hearing impairment (greater than 70 dB).
3. Patients having symptoms of Badhirya (SNHL) persisting for more than 12 months.
4. Patients with Otorrhoea.
5. Conductive & mixed hearing loss.
6. Pregnant women
7. Patients who require otological surgical intervention.
8. Malignancy related to the external, middle, and internal ear.
9. Patients with systemic illnesses like DM, Hypertension, Tuberculosis…etc. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Reduction in scoring pattern of sign and symptoms of Badhirya (Sensorineural Hearing Loss)
|
Reduction in scoring pattern of sign and symptoms of Badhirya (Sensorineural Hearing Loss)
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in associated symptoms of Badhirya i.e karnanada
Improvement in Quality of Life by a validated questionare (QOL) |
Improvement in associated symptoms of Badhirya i.e karnanada
Improvement in Quality of Life by a validated questionare (QOL) |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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
|
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Brief Summary
|
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.
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