Kudzu root may rewire the Body's Drug-Clearing machinery

NCT ID NCT07823140

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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The treatment has been approved, so it is available normally rather than through this programme.

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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are studying whether kudzu root, a traditional Chinese herb also called Gegen, changes the activity of liver enzymes that break down many medicines. Fifty-six healthy Chinese adults take a cocktail of probe drugs before and after receiving low or high doses of kudzu root, and blood tests measure enzyme activity and clotting markers. The goal is to see if the herb could cause herb-drug interactions and whether the effect depends on dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
kudzu root (Gegen, Radix Puerariae lobatae) herbal granules
What this could lead to
If kudzu root changes how the body processes medicines, doctors could warn patients about mixing the herb with certain drugs and adjust doses to keep them safe.
What could go wrong
This is a small Phase 1 study in healthy adults, so any enzyme changes seen may not translate to real-world drug interactions or to people who are sick. Herbal products also vary in strength and quality.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

56 people

The number who actually took part.

Started

Aug 2022

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and non-pregnant female Chinese subjects, 20 - 45 years of age. 2. Body weight within 15% of ideal weight (according to the Metropolitan InsuranceCompany Bulletin). 3. Accessible vein for blood sampling. 4. High probability for compliance and completion of the study. 5. Female subjects who are surgically sterile or post-menopausal. Or female subjects of child bearing potential agree to practice abstinence or take effective contraceptive methods (e.g. non-hormonal intra-uterine device, consistent condom plus spermicide use or consistent cervical cap with spermicide) from the start of screening until two weeks of last dose administration to prevent pregnancy. 6. Male subjects agree to practice abstinence or take effective contraceptive method (refer to the aforementioned) from the start of screening until two weeks of last dose administration to prevent his partner pregnant. 7. Subjects agree to abstain from any prescription or non-prescription medications 2 weeks before the first dosing and throughout the study (except those allowed based on investigator's judgement). 8. Have signed the written informed consent to participate in the study. Exclusion Criteria: 1. Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study. 2. Clinically significant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test. 3. Tobacco uses in any forms. 4. Positive results of hepatitis B. 5. Regular consumer of alcohol (on average more than one drink per day within 1 month prior to the start of first dosing). 6. Consumer of Asian vegetables, fruits or other herb medicine which are known to contain moderate to high levels of furanocoumarins, such as grapefruit juice, or herbal teas that naturally contain coumadin or coumadin-like substances such as Chamomile tea. 7. Have lost or donate more than 350 ml blood donation within 4 weeks prior to the start of the study. 8. Administer any prescription or non-prescription medications which is likely to be required during the course of the study (except those allowed based on investigator's judgement). 9. Treatment of Gegen or the studied probe drugs (caffeine, losartan, omeprazole, metoprolol, midazolam, efavirenz) within 2 weeks before the study. 10. Volunteer in any clinical drug study within 1 month prior to this study 11. History of allergy or hypersensitivity to Gegen or the studied probe drugs (caffeine, losartan, omeprazole, metoprolol, midazolam, efavirenz) and other drugs in its class. 12. History of drug abuse in any form. 13. Genetics of the studied six CYPs revealed no enzyme activity (homozygous), including following genetic variants: CYP2C9\*25, CYP2C19\*2, CYP2C19\*3, CYP2C19\*4, CYP2C19\*35, CYP2D6\*4, CYP2D6\*6, CYP3A4\*20. 14. Female subjects who are breastfeeding or pregnancy. 15. Subjects who are considered not suitable in participating the study due to other unfavourable factors determined by investigators. 16. History or presence of problem in swallowing capsules and/or Chinese medicine.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Chinese University of Hong Kong Phase 1 Clinical Trial Centre

    Hong Kong, Hong Kong

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