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Anti-inflammatory Drug

Diclofenac + Curcumin for Drug Interactions

Phase < 1

Recruiting

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of diclofenac or curcumin

Be older than 18 years old

Must not have

History of anemia or any other significant hematologic disorder

Use cannabis products, including marijuana, hemp, and other THC- or CBD-containing products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-12 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how a drug-metabolizing enzyme & an herbal product affect a widely-used medication. Results will inform future studies on drug effects & risk of toxicity.

Who is the study for?

This trial is for healthy adults aged 18-64 who don't have major illnesses like kidney or liver disease, diabetes, heart conditions, or cancer. Participants must not be on medications that affect diclofenac or curcumin and should avoid caffeine and alcohol before study days. They can't smoke, use cannabis products, be pregnant/nursing, or planning pregnancy soon after the trial.

What is being tested?

The study is testing how a natural product called curcumin affects the breakdown of diclofenac—a common pain reliever—by inhibiting an enzyme known as UGT2B17. This pilot study will help design future research on genetic differences in drug metabolism and potential toxicity risks.

What are the potential side effects?

Possible side effects may include digestive issues due to diclofenac such as stomach pain, nausea, and increased risk of bleeding. Curcumin might cause mild symptoms like bloating or allergic reactions in sensitive individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on medications or supplements that affect diclofenac or curcumin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of anemia or other significant blood disorders.

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I use cannabis products like marijuana or CBD.

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I am taking medications or supplements that affect how diclofenac or curcumin works in my body.

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I am currently taking turmeric or curcumin supplements.

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I am either younger than 18 or older than 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diclofenac AUC in EMs in the presence of curcumin

Diclofenac AUC in poor metabolizers (PMs)

Diclofenac CLr in EMs in the presence of curcumin

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: diclofenac + curcuminExperimental Treatment2 Interventions

A single oral dose of diclofenac (25 mg capsule) and a single oral dose of curcumin (2,000 mg tablet) will be administered by mouth to the 5 participants genotyped as extensive metabolizers. Plasma and urine will be collected from 0-12 hours.

Group II: Arm 1: diclofenac alone (baseline)Experimental Treatment1 Intervention

A single dose of diclofenac (25 mg capsule) will be administered by mouth to 5 participants (minimum 2 females) genotyped as extensive metabolizers (Arm 1A) and 5 participants (minimum 2 females) genotyped as poor metabolizers (Arm 1B). Plasma and urine will be collected from 0-12 hours. A washout of at least 3 days will elapse between Arm 1 and Arm 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diclofenac

2014

Completed Phase 4

~13430

curcumin

2017

Completed Phase 4

~1180