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NCT03948243 · ClinicalTrials.gov registry record · Phase 1
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
A Phase 1 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03948243: Completed Phase 1 study, sponsored by University of Illinois at Chicago.
NCT03948243 is a Phase 1 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03948243, a Phase 1 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.
Primary Outcome
Concentration of probe drugs from blood draws during the 14-day intervention will be used to calculate area under the (extrapolated) concentration-time curve to determine any changes compared to pre-intervention.
Interventions
- DIETARY_SUPPLEMENT Licorice
- DRUG Alprazolam 2 MG
- DRUG Caffeine 100 MG
- DRUG Tolbutamide 250 mg
- DRUG Dextromethorphan 30mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-04-22 |
| Phase | Phase 1 |
What the finished NCT03948243 record still lists
NCT03948243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Licorice is the first listed.
NCT03948243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03948243 about?
NCT03948243 is a clinical study titled "Licorice Botanical Dietary Supplements - Metabolism and Safety in Women". Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the Universit...
What is the current status of trial NCT03948243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-04-01. Estimated completion is 2022-04-22.
What interventions are being tested in trial NCT03948243?
The interventions under investigation include: Licorice (DIETARY_SUPPLEMENT), Alprazolam 2 MG (DRUG), Caffeine 100 MG (DRUG), Tolbutamide 250 mg (DRUG), Dextromethorphan 30mg (DRUG).
Who is sponsoring clinical trial NCT03948243?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03948243's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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