Clinical TrialID 71

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

NCT05081583

Interaction, Adverse Herb-Drug|Diabetes Mellitus, Type 2

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
71
Evidence Id
71
Core Evidence Id
71
Source Clinical Trial Id
66
Herb2 Clinical Trial Id
HBCT000066
Nct Id
NCT05081583
Title
Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
Status
Active_Not_Recruiting
Phase
Early_Phase 1
Study Result
No
Study Condition
Interaction, Adverse Herb-Drug|Diabetes Mellitus, Type 2
Study Type
Interventional
Study Design
Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Intervention
DRUG: Midazolam Hcl 1Mg/Ml Inj|DIETARY_SUPPLEMENT: Goldenseal (Hydrastis canadensis)
Intervention Allocation
Non_Randomized
Intervention Model
Crossover
Intervention Mask
Intervention Purpose
Basic_Science
Gender
All
Age
Adult, Older_Adult
Enrollment
22
Outcome Measure
Metformin area under the concentration vs. time curve (AUC) ratio (exposure/baseline), Ratio of the area under the plasma concentration time curve (AUC) of metformin in the presence to absence of goldenseal., 0-24 hours
Sponsor Collaborator
Washington State University|National Center for Complementary and Integrative Health (NCCIH)
Funded By
OTHER
Location
Washington State University College of Pharmacy and Pharmaceutical Sciences, Spokane, Washington, 99202, United States
Other Id
18889-002|U54AT008909
Start Date
2021-09-16
Primary Completion Date
2023-01-16
Completion Date
2023-08-31
First Posted
2021-10-18
Results First Posted
Last Update Posted
2023-05-10
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05081583
Title Cn
Title En
Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
Bilingual Status
semi_complete