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 | ✓ |
|
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|
|
|
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|
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Provision of participant information sheet | ✓ |
|
|
|
|
|
|
|
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|
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Eligibility assessment | ✓ |
|
|
|
|
|
|
|
|||||||||
|
|
Informed consent | ✓ |
|
|
|
|
|
|
|
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| Interventions | ||||||||||||||||||
|
|
Ashwagandha Churna days 1-168 |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
|||||||||
|
|
Karnapurana: weeks 1,5,9,13,17,21 |
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
|
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|
|
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 |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||||||