Kudzu root may rewire the Body's Drug-Clearing machinery
NCT ID NCT07823140
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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56 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Apr 2023
- Lead sponsor
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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
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20 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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The Chinese University of Hong Kong Phase 1 Clinical Trial Centre
Hong Kong, Hong Kong
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