JMIR Publications

ABSTRACT

Background:

Presbycusis is characterized by sensorineural hearing loss in both ears at high frequencies, which affects more than half of older adults by age 75 and is often accompanied by tinnitus and cognitive deterioration. Unfortunately, there are no treatments available to restore hearing loss. Treatment in the majority of cases focuses on improving the quality of life and communication by hearing aids, which have their limitations and drawbacks. Management of tinnitus (ringing in ears) usually associated with Presbycusis is further challenging. Cognitive dysfunction in older adults following hearing loss is another concern that needs to be addressed. Multispecialty approaches involving neurology, audiology, gerontology, and otolaryngology are usually required to manage Presbycusis. Traditional medicine like Ayurveda also explains ailments of similar nature as Bhaadirya and advises using drugs with anti-aging and neuroprotective activity for treatment. In Ayurveda, the condition Baadhirya and Karnanada (senile deafness with tinnitus) is due to vitiation of Vata dosha. Treatments like topical oil pooling (Karnapurana) are usually advised in such conditions to counter Vata, improve hearing capacity, and reduce tinnitus. Kshirabala taila, a medicated oil formulation prepared with Sida cordifolia Linn, is one of the most preferred oils for topical oil pooling in such conditions as it has a definitive indication for sensory dysfunctions. Drugs like Ashwagandha (Withania somnifera L Dunal) are also used as it acts on neurodegeneration and helps to improve cognitive dysfunction. Although found effective in clinical practice, no documented data or clinical trials are found on the effectiveness of these interventions in Presbycusis. The only available data is a case report which reported significant improvement in hearing mechanism with no adverse effects following treatment.

Objective:

Hence, an exploratory randomized controlled trial study has been proposed for evaluating the efficacy of Topical Oil Pooling (Karnapurana) with Kshirabala Taila and suppleMentation of Ashwagandha Churna (TOPMAC) on tinnitus suppression hearing and cognitive function protection in patients aged 60-75 years with mild to moderate Presbycusis against Basic Treatment and Health Education (BTHE).

Methods:

A parallel, two-group, exploratory RCT conducted in an Indian Ayurvedic research centre at its outpatient service. Participants (n =60) with mild to moderate Presbycusis will be recruited by screening. Participants will be randomised (computer-generated: 1:1) to receive either: Basic Treatment and Health Education (BTHE) for 24 weeks/BTHE +TOPMAC. The Primary objective is to compare the efficacy of TOPMAC weeks on hearing function protection against BTHE. The Secondary objectives are to compare its efficacy on tinnitus suppression and cognitive function protection against BTHE.

Results:

Nil

Conclusions:

If this exploratory trial is proven effective, it will steer the setting of a definitive RCT to test whether the TOPMAC intervention can be incorporated as a cost-effective integrative approach for managing Presbycusis. The Government of India has already launched a National Programme for Prevention and Control of Deafness (NPPCD) to benefit the deaf population. TOPMAC may later be considered for integration with programmes like NPPCD. Clinical Trial: CTRI/2023/04/051485. Registered 11/04/2023.http://ctri.nic.in