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Anti-diabetic Drug

Goldenseal (Hydrastis canadensis) for Type 2 Diabetes

Q: What health issues have traditionally been addressed with Goldenseal (Hydrastis canadensis)?

Goldenseal (Hydrastis canadensis) is a popular herb used in treating <a href="https://www.withpower.com/clinical-trials/anxiety">anxiety</a>. Other applications include inducing amnesia, mitigating status epilepticus, and providing anxiolytic therapy.

Q: Has there been any previous research into the efficacy of Goldenseal (Hydrastis canadensis) as a therapeutic supplement?

Currently, 65 studies examining the effectiveness of Goldenseal (Hydrastis canadensis) are active; 10 trials have moved into Phase 3. Though concentrated in Porto Alegre, <a href="https://www.withpower.com/clinical-trials/california">California</a>, 724 centres worldwide are conducting clinical research on Goldenseal (Hydrastis canadensis).

Q: How many participants have registered for this research project?

This research project is not presently recruiting candidates. It was initiated on September 16th 2021 and last modified November 18th 2022. If you're looking for alternative studies, there are 790 trials actively seeking individuals with <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus type 2 and 65 investigations involving Goldenseal (Hydrastis canadensis) that require participants.

Q: Are there currently any opportunities to participate in this medical research?

As of the November 18th 2022 update, this specific trial has finished recruiting. It was originally posted on September 16th 2021 and is no longer actively searching for participants. If you are looking to join a different study, there are 790 clinical trials currently enrolling patients with <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus type 2, while 65 studies are seeking volunteers for Goldenseal (Hydrastis canadensis).

Q: Is this research endeavor seeking participants that are elder than 35 years of age?

This clinical trial necessitates that potential participants are between the ages of 18 to 65. An alternative 71 studies exist for those below 18 and an additional 718 studies accommodate patients over 65 years old.

Q: Is there an opportunity to be involved in this medical study?

This clinical trial is looking to recruit 22 individuals aged between 18 and 65 that have been medically diagnosed with <a href="https://www.withpower.com/clinical-trials/type-2-diabetes">Type 2 diabetes</a>. In addition, these prospective participants must currently be taking metformin (1-2g daily), possess an HbA1c &#x3C; 8%, abstain from medications, dietary/herbal supplements or citrus juices capable of interfering with study drugs' elimination as well as alcohol, caffeinated beverages and other caffeine-containing products the evening before and morning of their first day in each arm of the trial. Furthermore, female participants are expected to utilize a form of contraception not including oral <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> pills or patches such as abstinence

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

Study Summary

This trial will study how goldenseal, a natural product, interacts with metformin, a diabetes drug, and how it could help people with diabetes.

Eligible Conditions

Type 2 Diabetes
Herb-Drug Interactions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-24 hours

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

101 Previous Clinical Trials

56,692 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

831 Previous Clinical Trials

668,911 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health issues have traditionally been addressed with Goldenseal (Hydrastis canadensis)?

"Goldenseal (Hydrastis canadensis) is a popular herb used in treating anxiety. Other applications include inducing amnesia, mitigating status epilepticus, and providing anxiolytic therapy."

Answered by AI

Has there been any previous research into the efficacy of Goldenseal (Hydrastis canadensis) as a therapeutic supplement?

"Currently, 65 studies examining the effectiveness of Goldenseal (Hydrastis canadensis) are active; 10 trials have moved into Phase 3. Though concentrated in Porto Alegre, California, 724 centres worldwide are conducting clinical research on Goldenseal (Hydrastis canadensis)."

Answered by AI

How many participants have registered for this research project?

"This research project is not presently recruiting candidates. It was initiated on September 16th 2021 and last modified November 18th 2022. If you're looking for alternative studies, there are 790 trials actively seeking individuals with diabetes mellitus type 2 and 65 investigations involving Goldenseal (Hydrastis canadensis) that require participants."

Answered by AI

Are there currently any opportunities to participate in this medical research?

"As of the November 18th 2022 update, this specific trial has finished recruiting. It was originally posted on September 16th 2021 and is no longer actively searching for participants. If you are looking to join a different study, there are 790 clinical trials currently enrolling patients with diabetes mellitus type 2, while 65 studies are seeking volunteers for Goldenseal (Hydrastis canadensis)."

Answered by AI

Is this research endeavor seeking participants that are elder than 35 years of age?

"This clinical trial necessitates that potential participants are between the ages of 18 to 65. An alternative 71 studies exist for those below 18 and an additional 718 studies accommodate patients over 65 years old."

Answered by AI

Is there an opportunity to be involved in this medical study?

"This clinical trial is looking to recruit 22 individuals aged between 18 and 65 that have been medically diagnosed with Type 2 diabetes. In addition, these prospective participants must currently be taking metformin (1-2g daily), possess an HbA1c < 8%, abstain from medications, dietary/herbal supplements or citrus juices capable of interfering with study drugs' elimination as well as alcohol, caffeinated beverages and other caffeine-containing products the evening before and morning of their first day in each arm of the trial. Furthermore, female participants are expected to utilize a form of contraception not including oral birth control pills or patches such as abstinence"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients

Mary Paine 2021. "Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081583.