| CTRI Number |
CTRI/2026/01/100330 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Nirgundyadi Taila karnapoorana in the management of Karnanada -Tinnitus |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL DOUBLE ARM CONTROLLED CLINICAL
STUDY TO EVALUATE THE EFFICACY OF NIRGUNDYADI TAILA
KARNAPOORANA IN MANAGEMENT OF KARNANADA (TINNITUS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhu T G |
| Designation |
PG Scholar |
| Affiliation |
SDMIAH Bangalore |
| Address |
Shalakya tantra Department,
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Shalakya tantra Department,
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
7619514986 |
| Fax |
|
| Email |
mmadhutg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharanprasad Kolliyavar |
| Designation |
Associate professor |
| Affiliation |
SDMIAH Bangalore |
| Address |
Shalakya tantra Department OPD-10,
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9844897784 |
| Fax |
|
| Email |
drsharanprasad.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharanprasad Kolliyavar |
| Designation |
Associate professor |
| Affiliation |
SDMIAH Bangalore |
| Address |
Shalakya tantra Department OPD-10,
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,
Bengalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9844897784 |
| Fax |
|
| Email |
drsharanprasad.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheswara Institue of Ayurveda hospital, Bangalore 560074 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
SDMIAH Bangalore, 560074 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Madhu |
SDMIAH Bangalore |
Shalaya tantra Opd-10,11,16 & 22, sdm institute of aurveda hospital, Anchepalya, Bangalore
Bangalore
KARNATAKA |
7619514986
mmadhutg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Commitee SDMIAH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:3||Administration. Ayurveda Condition: KARNA-NADAH, (2) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nirgundyadi taila, Reference: Yogaratnakara, Route: Otic, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gudchibala taila, Reference: chikitsa Manjari, Route: Otic, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 20 -50 years will be selected.
2.Tinnitus induced by psychogenic factors such as anxiety and stress.
3.Pure tone audiometry readings within normal limits (0- 20 dB)
|
|
| ExclusionCriteria |
| Details |
1.Perforated tympanic membrane
2.Middle ear pathologies such as acute and chronic suppurative otitis media
3.Hearing impairments of different variants
4.Menier’s disease and Benign Paroxysmal Positional Vertigo (BPPV) 5. Patient with systemic disease like Anaemia, Hypertension, Diabetic mellitus.
6. Tumours of the ear inducing tinnitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant Reduction in the perception and severity of subjective tinnitus sounds |
Significant Reduction in the perception and severity of subjective tinnitus sounds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Decrease in scores of the tinnitus handicap inventory questionnaire compared to baseline.
•Improvement in the score of CGI-I from baseline.
|
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/01/2026 |
| 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 Applicable |
| 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
|
The study is a randomized, open-label, double-arm controlled clinical trial designed to evaluate the efficacy of Nirgundyadi Taila Karnapoorana in managing Karnanada (tinnitus). The trial involves 40 participants aged 20 to 50 who experience subjective sounds like ringing or buzzing due to psychogenic factors. The primary objective is to analyze the effect of Nirgundyadi Taila in relieving these symptoms compared to a control group receiving Guduchibala Taila. Participants are excluded if they present with organic ear pathologies such as perforated tympanic membranes, middle ear infections, or systemic diseases like hypertension and diabetes. Both groups undergo two sittings of Karnapoorana, which involves pooling the medicated oil in the ear for approximately five minutes daily over seven days, followed by a seven-day interval. Progress is measured using the Tinnitus Handicap Inventory (THI) and the Clinical Global Impression of Improvement (CGI-I) scale, with assessments performed at baseline, on the 8th day, and on the 22nd day. The statistical analysis will utilize Wilcoxon signed-ranks and Mann-Whitney U tests to determine if there is a significant difference between the trial and control interventions. Karnanada, described in Ayurveda, refers to the perception of internal ear sounds caused by vitiated Vata dosha affecting the auditory pathways (Shabdavaha srotas). It correlates with tinnitus in modern medicine, a condition where individuals hear sounds like ringing or buzzing without external stimuli. Tinnitus affects a significant portion of the global population, increasing with age, and is managed through medications, psychotherapy, and lifestyle changes, though no definitive cure exists. Ayurvedic treatments focus on pacifying Vata through therapies like Snehana, Swedana, Snehavirechana, and especially Karnapoorana—a localized oil therapy that nourishes auditory nerves. Oils like Guduchibala taila and Nirgundyadi taila, known for their Vata-pacifying properties, have shown promising results in managing Karnanada effectively and safely.
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