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The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions
Plain-language guide to NCT05104424: phase 1 randomized trial of Insulin Aspart, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05104424
- Phase
- phase 1
- Status
- status unknown
- Start
- 2021-12-26
- Completion (planned or actual)
- 2022-08-26
- Participants
- 22 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Smell Dysfunction; Taste Disorders; Taste Disorder, Secondary, Sweet; Taste Disorder, Secondary, Bitter; Smell Disorder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Aspart.
It had two arms (groups): adult post covid-19 recovered 22 patients with smell and taste dysfunction take quadruple therapy (active comparator) and patients taking zinc only with smell training on volatile oils (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 22 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Adult male or female recovered patients only postcovid-19 no other interventional treatment.
The full record lists 1 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2021-12-26 with completion listed for 2022-08-26.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: evaluation of disturbances of smell and taste (Sniffin 'Sticks" test) (time frame: 4 month). evaluation of taste disorders (time frame: 4 month). questionnaire for taste self assessment ( Dynachron-olfaction questionnaire) (time frame: 4 month).
It also tracked 1 secondary outcome, for example any clinical manifestations or adverse effects.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Aspart in 22 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Aspart compound page, all human trials.
Our Notes on the Compound
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.