Comparative efficacy of Bilva Taila prepared on principle of Snehapaka in the management of Karnanada(tinnitus)
- Conditions
- Tinnitus. Ayurveda Condition: KARNA-NADAH,
- Registration Number
- CTRI/2023/07/055314
- Lead Sponsor
- Government Ayurved Hospital, Vadodara
- Brief Summary
A clinical study was conducted following approval from theInstitutional Ethics Committee (GAV/VAD/IEC/79/2023, dated 13/03/2023) andregistered with the Clinical Trial Registry of India, ICMR, New Delhi(CTRI/2023/07/055314, registered on 18/07/2023). This was an interventional,randomized double-blind design. Criteria for selection, demographic details andhistory of present illness of patients were noted in designed clinical proforma(Annexure 6). A detailed description of the diagnostic criteria for *Karnanada*(tinnitus) was provided, along with both subjective and objective assessmentcriteria for evaluating outcomes. A specialized scoring system was implementedto assess results in terms of percentage relief, accompanied by statisticalevaluation. The findings and results were presented in tabular and graphical format,followed by a thorough interpretation of the data and assessed the overallefficacy of the test drugs.
In this study, a total of 70 patients were screenedout for assessment of eligibility criteria. But according to the inclusion andexclusion criteria, among them total 30 patients were excluded as they weremeet with exclusion criteria and 40 patients were selected randomly andallocated into two groups, with 20 patients in each group (Group A and GroupB). Of these, 36 patients completed the treatment regimen—19 in Group A and 17in Group B.
Blinding of test drug was done on 23rd March 2024 andcode (i.e. BT-1 to BT- 40) was labelled on medicine. BTC and BTS, respectively,at a dosage of 24-26 drops administered for duration of 100 *Matra*(approximately 5 mins), once daily in the evening for 21 days. The totalduration of the trial was 3 weeks, followed by a 2-weeks follow-up period. Observationaldata were collected on demographic parameters, including age, sex, andoccupation, as well as cardinal symptoms such as *Vividha Shabda Shravana*(perception of various abnormal sounds) and *Badhirya* (hearing loss), inaddition to the Tinnitus Handicap Inventory (THI). The effect of the treatmenton all signs and symptoms of the condition were recorded before and after thetreatment period. Laboratory investigations such as haemoglobin percentage(Hb%) and random blood sugar (RBS) were conducted for the enrolment ofpatients. Additionally, pure tone audiometry was performed before and aftertreatment on patients presenting with hearing loss to assess changes inauditory function. The data were meticulously documented and analysed. Acommittee was conducted the process for disclosure of code (on 11th September2024) and reveals that group A received *Bilva Taila* prepared accordingto the reference of Chakradatta (BTC), while group B received *Bilva Taila*prepared on *Snehapaka* principle according to the reference ofSharangdhara Samhita (BTS).
The demographic analysis revealed that the maximum patients (32.50 %)belonged to the age group of 31 to 40 years. Female patients constituted 52.50 %of the sample, while married individuals made up 80 %. The majority ofparticipants identified as Hindu (95 %). In terms of occupation, the mostrepresented group was those employed in service positions (45 %), with 85 % of the patientsbelonging to the lower middle class.
Furthermore, the predominant constitutional types observed were *Vata-PittaPrakriti* (62.50 %) and *Rajasika Manasa Prakriti* (67.50 %). Mostpatients exhibited *Madhyama Satva* (62.50 %), *Madhyama Samhanana*(65 %) and *Madhyama Pramana* (87.50 %). Additionally, a significantmajority demonstrated *Madhyama Satmya* (95 %), *Madhyama Vyayama Shakti*(72.50 %), *Madhyama Abhyavarana Shakti* (87.50 %) and *Madhyama Koshtha*(57.50 %). These findings indicate a consistent profile among the patientpopulation in this study.
The analysis of dietary habits revealed that *Katu Rasa* was the predominant dietarypreference, identified in 47.50% of the patients as an etiological factor.Among the enrolled patients, *Guru*(60 %) and *Snigdha* (55 %)were the most commonly consumed qualities of food. Additionally, the studyfound that *Marut Sevana*(82.50 %), *Karnakanduyana*(57.50 %), and *Shrama* (52.50 %)were the principal causative factors associated with the condition.
The majority of patients (67.50 %) developed the condition within a year,with 52.50 % reporting a sudden onset of symptoms. Notably, 70 % of patients wereexperienced a stationary phase of tinnitus. Symptoms were exacerbated in aquiet environment for 87.50 % of the patients. Various abnormal sounds wereheard by the patients (i.e. Ringing, whistling, roaring, hissing, etc.) but most frequently reported auditory symptomwas a ringing sound in the ear, observed in 35 % of cases. Furthermore, afamily history of tinnitus was absent in all patients (100 %). All patientsexhibited symptoms consistent with *Karnanada*, while only 27.50 %reported associated complaints of *Badhirya*.
Bothtreatment groups exhibited highly significant improvements in Karnanadasymptoms and the Tinnitus Handicap Inventory (THI), while no significantchanges were observed in Badhirya symptoms. Comparative analysis revealed thatrelief in Karnanada symptoms was 63.41 % in Group A and 56.76 % in Group B, adifference that was statistically insignificant (P > 0.05). Similarly, forthe THI, Group A showed a relief of 67.18% compared to 64.15% in Group B, whichalso indicates statistical insignificance (P > 0.05). In terms of Badhirya,both groups demonstrated no improvement (0 %), as the maximum enhancementobserved in audiometry was only 5 dB, which did not translate into meaningfulchanges in the scoring pattern.
In Group A,36.84 % of patients achieved complete remission, while in Group B, this ratewas significantly lower at 5.88 %. Marked improvement was noted in 5.26 % ofpatients in Group A, compared to 11.76 % in Group B. Moderate improvement wasreported in 21.05 % of patients in Group A, in contrast to 47.05 % in Group B.Additionally, mild improvement was observed in 10.52 % of patients in Group Aand 23.52 % in Group B. Furthermore, 26.31 % of patients in Group A and 11.76 %in Group B exhibited no change in their condition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Patients having perception of different types of sound in ear canal.
- Patients suffering from any chronic debilitating disease like Diabetes, Hypertension, Kochs disease, Carcinoma, Anemia, and with other ear pathologies.
- Cases which required surgical intervention.
- Patients below the age of eighteen years and above sixty years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in THI scoring pattern of Karnanada(Tinnitus) 21 days
- Secondary Outcome Measures
Name Time Method Improvement in associated symptoms like Badhirya(Hearing loss), Vertigo, Headache. 35 days
Trial Locations
- Locations (1)
Government Ayurved Hospital Vadodara
🇮🇳Vadodara, GUJARAT, India
Government Ayurved Hospital Vadodara🇮🇳Vadodara, GUJARAT, IndiaDr Darshita A SanchaniyaPrincipal investigator9106961576d.sanchaniya8@gmail.com