Status:
COMPLETED
Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach
Lead Sponsor:
Washington State University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Interaction Drug Food
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Goldenseal is a botanical natural product commonly used to self-treat symptoms of the common cold and many digestive disorders. Goldenseal products typically contain the isoquinoline alkaloids berberi...
Detailed Description
Many patient groups often supplement their pharmacotherapeutic regimens with herbal and other natural products (NPs), raising concern for adverse interactions with conventional drugs. Unlike for drug-...
Eligibility Criteria
Inclusion
- Ability to participate in the study (time, transportation, etc.)
- Ability to understand the informed consent form
- Men and women aged from 18 to 65 years
- Willingness to abstain from alcohol and caffeinated beverages for the evening prior to and during each in-patient study day
- Willingness to abstain from citrus juices and other dietary supplements for the duration of the study
Exclusion
- Any current major illness or chronic illness including but not limited to kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, previous stroke or embolic disease history, cancer, and HIV/AIDS
- History of allergy to goldenseal, midazolam, furosemide, metformin, or rosuvastatin
- History of anemia or any other significant hematologic disorder
- History of renal failure or lactic acidosis (metformin)
- History of apnea (midazolam)
- History of heart failure, electrolyte imbalance (furosemide)
- History of hypotension (goldenseal)
- History of drug or alcohol addiction or major psychiatric illness
- Women who are intending to become pregnant within the next three months, are currently pregnant, or are currently breastfeeding
- Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk
- Taking concomitant medications, both prescription and non-prescription (including herbal/natural products) known to alter the pharmacokinetics or pharmacodynamics of midazolam, furosemide, metformin, or rosuvastatin.
Key Trial Info
Start Date :
April 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03772262
Start Date
April 5 2018
End Date
March 31 2019
Last Update
April 28 2023
Active Locations (1)
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1
Washington State University
Spokane, Washington, United States, 99202