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A clinical trial to compare Ayurvedic medicated oil put in the ears with the same treatment plus an Ayurvedic powder taken by mouth in people with ringing or buzzing in the ears and hearing loss due to inner ear or hearing nerve problems

Efficacy Of Apamargakshara Taila Karnapurana With And Without Rasayana Churna In The Management of Karnanada W.S.R. To Tinnitus Associated With Sensorineural Hearing Loss An Open Labelled Randomized Comparative Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110985
Enrollment
30
Registered
2026-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H833- Noise effects on inner ear

Interventions

None listed

Sponsors

Institute Of Teaching And Research In Ayurveda, Jamnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the age of eighteen to fifty years 2. Patients will be selected on the basis of signs and symptoms of karnanada tinnitus associated with sensorineural hearing loss described as per Ayurvedic texts as different types of sound sensation in ear like bheri (cuttle drum sound) mrudunga (roaring sensation) shankha (ringing sensation) 3. Diagnosis of subjective non pulsatile tinnitus (uni or bilateral) that is persistent (commonly more than or equal to 3 months) 4. Sensorineural hearing loss confirmed by Pure Tone Audiometry (PTA) 5. Stable baseline care (no new tinnitus treatments started within last 2 to 4 weeks such as hearing aid fitting, CBT initiation, new meds aimed at tinnitus, etc 6. Ability to comply willing for daily ear procedure, taking oral medicine, coming for follow ups and provide informed consent

Exclusion criteria

Exclusion criteria: 1. Patients below the age of eighteen and above the age of fifty years. 2. Patients suffering from any chronic debilitating diseases such as uncontrolled hypertension, uncontrolled diabetes, uncontrolled thyroid disease, severe anemia or B12 deficiency not corrected. 3. Patients suffering from pulsatile tinnitus, objective tinnitus or complex auditory hallucinations and psychosis-related symptoms; 4. Patients suffering from otosclerosis, otomycosis, active otitis externa or otitis media, chronic suppurative otitis media, cholesteatoma, tympanic membrane perforation or grommet/ear surgery history, impacted wax at baseline, 5. Cases which require surgical intervention and cases with history of ear surgery. 6. Patients suffering from vestibular/cochlear disorders with fluctuating course, M ni re s disease, endolymphatic hydrops, recent sudden SNHL (e.g., within last 3 months) or rapidly progressive hearing loss 7. Patients on current or recent exposure to ototoxic drugs (e.g., aminoglycosides, cisplatin, loop diuretics, high-dose salicylates), ongoing benzodiazepine dose changes, recent antidepressant initiation or dose change, substance dependence (alcohol/drugs) affecting adherence and symptom reporting 8. Patient with ear canal pathology that makes oil instillation unsafe/painful (eczema flare, severe dermatitis, stenosis) or known allergy to the ingredients 9. Patient currently participating in another interventional trial or unable to complete validated questionnaires reliably

Design outcomes

Primary

MeasureTime frame
Efficacy of the intervention on signs and symptoms of Karnanada (tinnitus associated with SNHL) using tinnitus questionnaire and pure tone audiometry at the outset of the study and again after 30 days intervention.Timepoint: Pure tone audiometry and tinnitus questionnaire will be done at the outset and again after 30 days.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactMatheus H A de Macedo

Institute Of Teaching And Research In Ayurveda, Jamnagar

rsunadkat@itra.edu.in9427242598

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026