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. 2024 Sep 23;13:e55089. doi: 10.2196/55089

Table 1.

Schedule of enrollment, interventions, and assessments for the TOPMAC (Topical Oil Pooling with Kshirabala Taila and Supplementation of Ashwagandha Churna) study.


Screening Baseline Intervention period End of treatment
Timepoint
Day 1 Day 29 Day 57 Day 85 Day 113 Day 141 Day 169

Potential participant identification and screening







Provision of participant information sheet







Eligibility assessment







Informed consent






Interventions

Ashwagandha Churna days 1-168


Karnapurana: weeks 1,5,9,13,17,21


Basic treatment and health education

Assessments

Demographics







Tympanometry







Pure tone average





Speech recognition threshold





Speech discrimination score





Laboratory investigations





Brainstem Evoked Response Audiometry





Tinnitus Functional Index





Montreal Cognitive Assessment





Drug compliance (%)


Concomitant medication


Rescue medication


Adverse reactions