Evaluating the Pharmacokinetics of Oregano and Potential Oregano-drug Interactions Using a Drug Cocktail Approach

ConditionInteraction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorWashington State University

About this trial

The purpose of this clinical trial is to determine how the supplement oregano affects how the body metabolizes pharmaceutical drugs.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between 18-64 years old and healthy

Not taking any medications (prescription and non-prescription) or dietary/herbal supplements that can interfere with study drug pharmacokinetics

Willing to abstain from consuming dietary/herbal supplements and citrus juices for several weeks

Willing to abstain from cannabis/marijuana, hemp, and THC- and CBD-containing products for several weeks

Disqualifiers

Under 18 or over 64 years old

Taking medications or dietary/herbal supplements that can interfere with study drug pharmacokinetics

Have a major illness

Taking medication/supplements for a mineral deficiency

Trial design

Design model

Crossover

Treatments tested in this trial

  • Oregano

    Dietary supplement

    Oil of oregano administered as a softgel (180 mg).

  • Drug cocktail

    Drug

    Oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg).

Treatment groups

16 Participants
are divided into 4 treatment groups
Group A: Arm 1: oregano aloneExperimental treatment 1 intervention
Group B: Arm 2: drug cocktail aloneExperimental treatment 1 intervention
Group C: Arm 3: acute oregano + cocktailExperimental treatment 2 interventions
Group D: Arm 4: chronic oregano + cocktailExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Midazolam Area under the plasma concentration vs. time curve (AUC) ratio

Ratio of the area under the plasma concentration vs. time curve of midazolam in the presence to absence of oregano.

Time frame
0-24 hours

Secondary outcomes

1

Caffeine AUC ratio

Area under the plasma concentration vs. time curve of caffeine in the presence to absence of oregano.

Time frame
0-24 hours
2

Caffeine maximum plasma concentration (Cmax) ratio

Ratio of the maximum plasma concentration of caffeine in the presence to absence of oregano.

Time frame
0-24 hours
3

Caffeine half-life ratio

Ratio of the half-life of caffeine in the presence to absence of oregano.

Time frame
0-24 hours
4

Dextromethorphan AUC ratio

Area under the plasma concentration vs. time curve of dextromethorphan in the presence to absence of oregano.

Time frame
0-24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington State University

Lead sponsor

Office of Dietary Supplements (ODS)

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator