A RANDOMIZED OPEN LABEL DOUBLE ARM CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF NIRGUNDYADI TAILA KARNAPOORANA IN MANAGEMENT OF KARNANADA (TINNITUS)

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.