Oregano for Drug Interactions

Overseen By Mary F Paine, RPh, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington State University

Must not be taking: Prescription drugs, Supplements

Disqualifiers: Major illness, Mineral deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 73

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how oregano supplements might alter the body's processing of certain drugs. It compares the effects of oregano alone, a mix of common drugs (referred to as a "Drug Cocktail"), and both together to identify differences in absorption and breakdown. Individuals who are generally healthy, not taking conflicting medication or supplements, and live within 40 miles of Spokane may be suitable for this study. As an Early Phase 1 trial, this research aims to understand how oregano supplements function in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

Yes, you must stop taking any medications or supplements that could interfere with the study, as the trial requires participants to not be on any such medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that oregano is likely safe when consumed in food. However, there isn't enough reliable information to determine the safety of oregano as a supplement. As a common cooking herb, oregano has been used for its natural germ-fighting and protective qualities.

Regarding the drug combination, caffeine, dextromethorphan, losartan, midazolam syrup, and omeprazole are generally well-tolerated at their usual doses. These medications are commonly used for various conditions, such as controlling blood pressure or aiding sleep.

The study is in its early stages, focusing on understanding potential side effects and how well participants tolerate the treatments. Participants in early trials help researchers gather important safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of oregano in drug interactions because it introduces a natural product into the mix, potentially altering how the body processes medications. Unlike standard treatments that rely solely on drug formulations, oregano may influence the metabolism of drugs through its unique compounds. This trial could reveal if oregano can modify drug effects or reduce side effects, offering a complementary approach to traditional drug therapies. By exploring both acute and chronic administration of oregano, researchers are investigating if its effects can be harnessed consistently over time.

What evidence suggests that this trial's treatments could be effective for drug interactions?

This trial will explore the interactions between oregano and medications. Research has shown that oregano can interact with medications, potentially altering how the body processes drugs. The trial includes separate treatment arms to study these interactions: one arm will administer oregano alone, another will administer a drug cocktail alone, and additional arms will combine oregano with the drug cocktail. Studies suggest that oregano has strong germ-fighting abilities and can change the effectiveness or safety of some medications, especially those requiring precise dosages. Known for fighting viruses and fungi, oregano presents an interesting subject for studying how herbs and drugs might affect each other. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals interested in how oregano supplements might interact with certain drugs. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

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

I am willing to stop using cannabis, hemp, and THC/CBD products for several weeks.

I can avoid alcohol for 1 day before and on study days.

Exclusion Criteria

Currently using drugs or illicit substances for recreational purposes

I am taking medication or supplements for a mineral deficiency.

I have not used cannabis, hemp, or any CBD/THC products in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Oregano Alone

Participants receive 180 mg of a well-characterized oregano product. Blood and urine samples are collected over 24 hours.

1 day

Multiple visits within 24 hours

Treatment - Drug Cocktail Alone

Participants receive an oral drug cocktail. Blood and urine samples are collected over 24 hours.

1 day

Multiple visits within 24 hours

Treatment - Acute Oregano + Cocktail

Participants receive both the oregano product and the drug cocktail. Blood and urine samples are collected over 24 hours.

1 day

Multiple visits within 24 hours

Treatment - Chronic Oregano + Cocktail

Participants self-administer the oregano product at home for 5 days, followed by administration of the drug cocktail on day 6 with blood and urine collection.

6 days

1 visit on day 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Drug Cocktail
• Oregano

Trial Overview

The study investigates how taking oregano affects the body's ability to process a mix of different drugs (a 'drug cocktail'). This will help understand any potential interactions between oregano and common medications.

How Is the Trial Designed?

Group I: Arm 4: chronic oregano + cocktail Experimental Treatment 2 Interventions

The same 16 participants will self-administer the oregano product at home for 5 consecutive days. On day 6, participants will return to the study setting, where the procedure described in Arm 3 will be repeated.

Group II: Arm 3: acute oregano + cocktail Experimental Treatment 2 Interventions

The same 16 participants will be administered the oregano product and the drug cocktail. Blood and urine will be collected in the same manner described in Arm 1.

Group III: Arm 2: drug cocktail alone Experimental Treatment 1 Intervention

16 participants, which may or may not include any number of the original 6 from Arm 1, will be administered an oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg). Blood and urine will be collected in the same manner described in Arm 1.

Group IV: Arm 1: oregano alone Experimental Treatment 1 Intervention

6 participants will be administered 180 mg of a well-characterized oregano product. Blood will be drawn via an indwelling venous catheter immediately before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration of oregano. Urine will be collected in multiple jugs for 24 hours.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Office of Dietary Supplements (ODS)

Collaborator

Trials

55

Recruited

54,500+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Many herbal medicines, particularly those identified by Brazil's Unified Public Health System, lack sufficient pharmacokinetic data, which raises concerns about potential herb-drug interactions when used alongside conventional medications.

Most existing studies on these herbal medicines are in vitro, and there is a significant need for more research and monitoring to ensure the safety and efficacy of these treatments in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal medicines in Brazil: pharmacokinetic profile and potential herb-drug interactions. Mazzari, AL., Prieto, JM.[2021]

Herb-drug interactions can significantly affect the efficacy and safety of prescription medications, particularly those with a narrow therapeutic index like warfarin and digoxin, often due to metabolic induction or inhibition by herbal medicines.

Common herbs such as garlic, ginkgo, ginseng, and St. John's wort have been shown to interact with various drugs, leading to serious clinical consequences, highlighting the need for careful monitoring and further research on these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical herbal interactions with conventional drugs: from molecules to maladies. Chen, XW., Serag, ES., Sneed, KB., et al.[2019]

A review of 48 in vivo tests and 106 clinical trials suggests that multi-ingredient synergism in herbal products may contribute to their therapeutic efficacy, with 27 out of 39 cases showing positive interactions at the molecular level.

The findings indicate that the effectiveness of many herbal remedies could be due to the combined effects of multiple ingredients rather than just placebo, highlighting the importance of studying these interactions to understand their mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic therapeutic actions of herbal ingredients and their mechanisms from molecular interaction and network perspectives. Ma, XH., Zheng, CJ., Han, LY., et al.[2009]

The review identified 51 drug-herb interactions from 162 citations, with 22 of these interactions supported by clinical studies, highlighting the need for more research in this area.

Most interactions were pharmacokinetic, particularly affecting drug metabolism via cytochrome P450 enzymes, with warfarin and St. John's wort being the most frequently reported in these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-herb interaction among commonly used conventional medicines: a compendium for health care professionals. Brazier, NC., Levine, MA.[2019]

A systematic review identified 47 clinical trials examining interactions between natural health products (NHPs) and prescription medications, with an average of 14 participants per study, highlighting the limited research in this area.

Significant drug interactions were primarily observed with St. John wort, which showed potential interactions in 16 out of 24 studies, while other NHPs like garlic and American ginseng also indicated some interactions, but overall data on NHP-drug interactions remains sparse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural health product-drug interactions: a systematic review of clinical trials. Mills, E., Wu, P., Johnston, BC., et al.[2023]

Herbal medicines, which contain multiple active ingredients, have a higher potential for interactions with conventional drugs compared to synthetic medications, leading to significant clinical implications.

Certain herbs, like St John's wort, can induce enzymes that lower the effectiveness of various drugs, such as cyclosporine and oral contraceptives, posing risks for patients who rely on these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herb-drug interactions: an overview of the clinical evidence. Izzo, AA.[2007]

The review highlights that many commonly used herbs can significantly affect the activity of cytochrome P450 (CYP) enzymes and P-glycoprotein (P-gp), which are crucial for drug metabolism and transport.

Understanding how these herbs interact with CYP and P-gp can help optimize drug therapies, as these interactions may alter the effectiveness and safety of various medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic interactions of herbs with cytochrome p450 and p-glycoprotein. Cho, HJ., Yoon, IS.[2020]

Herbal medicine-drug interactions, particularly involving cytochrome P450 enzymes and drug transporters, can significantly affect the safety and efficacy of medications, especially those with a narrow therapeutic index like warfarin and digoxin.

The clinical implications of these interactions are complex and depend on various factors, including the specific herbal medicine used, the conventional drugs involved, and individual patient characteristics, highlighting the need for more controlled studies to better understand these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug interactions with herbal medicines. Shi, S., Klotz, U.[2022]

The study highlights two cases of cancer patients using natural compounds alongside chemotherapy, revealing significant risks such as severe adverse drug reactions (ADRs) and potential treatment ineffectiveness due to interactions with prescribed medications.

In one case, a patient experienced neutropenia due to the interaction between chemotherapy and natural products, while in another case, the use of St. John's Wort was avoided to prevent compromising the effectiveness of chemotherapy, emphasizing the importance of careful medication review in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity Derived from Interaction between Natural Compounds and Cancer Therapeutic Drugs Metabolized by CYP3A4: Lessons Learned from Two Clinical Case Reports. Orzetti, S., Baldo, P.[2023]

Herbal medications are often mistakenly perceived as completely safe due to their natural origins, but they can interact with pharmaceutical drugs, potentially affecting their efficacy and safety.

Understanding the mechanisms behind herb-drug interactions is crucial for healthcare providers to minimize clinical risks, as the concurrent use of herbs and medications can lead to significant safety concerns for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicinal herbs and therapeutic drugs interactions. Alissa, EM.[2014]

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