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Anti-diabetic Drug

Goldenseal (Hydrastis canadensis) for Type 2 Diabetes

Phase < 1
Waitlist Available
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours
Awards & highlights

Summary

This trial studies how goldenseal supplements affect the diabetes medication metformin in adults with type 2 diabetes. It aims to see if goldenseal changes how metformin is absorbed and processed, which could help create guidelines for using natural products with medications. Metformin is a commonly prescribed drug used primarily for managing type II diabetes.

Eligible Conditions
  • Type 2 Diabetes
  • Herb-Drug Interactions

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Metformin area under the concentration vs. time curve (AUC) ratio (exposure/baseline)
Secondary outcome measures
Metformin Cmax ratio (exposure/baseline)
Metformin half-life ratio (exposure/baseline)
Midazolam Cmax ratio (exposure/baseline)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Study Arm 3: Chronic Goldenseal ExposureExperimental Treatment2 Interventions
For Arm 3, the same 20 subjects will be administered goldenseal (1.1 g) orally three times daily for 27 days. On the 28th day, participants will be administered the goldenseal three times daily, as well as the single dose of midazolam (as described in Arm 1). Plasma and urine will be collected in a manner identical to that in Arm 1. A designated washout period for midazolam will not be necessary to separate Arm 3 from Arm 2 since there will be 27 days of goldenseal administration prior to the midazolam administration.
Group II: Study Arm 2: Acute Goldenseal ExposureExperimental Treatment2 Interventions
For Arm 2, the same 20 subjects will be administered a single dose of goldenseal (3.3 g) orally 30 minutes prior to administration of midazolam (as described in Arm 1). Plasma and urine will be collected in a manner identical to that in Arm 1. With respect to midazolam administration, a washout period of 7 days will separate Arm 2 from Arm 1.
Group III: Study Arm 1: BaselineExperimental Treatment1 Intervention
Twenty type 2 diabetic subjects (10 men, 10 women) will be administered a single dose of midazolam (0.5 mg) intravenously via a peripherally inserted catheter in conjunction with their daily oral administration of metformin. Plasma and urine will be collected from 0-24 hours post-midazolam administration. Participants will take their metformin as prescribed for the entirety of the study with no interruption in pharmacotherapy.

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Who is running the clinical trial?

Washington State UniversityLead Sponsor
104 Previous Clinical Trials
57,901 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
670,360 Total Patients Enrolled
~6 spots leftby Sep 2025
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