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Biomarker Changes and Anxiolytic Effects-Phase 2

NCT04565145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-08-13

Study results available
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Summary

This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic properties of kava. The investigators will conduct a one week, double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in adults with generalized anxiety disorder.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Kava Dietary Supplement

Participants will be given three 75mg kava capsules per day for one week

DRUG

Placebo

Participants will be given three placebo capsules per day for one week

Sponsors & Collaborators

  • Thorne HealthTech, Inc

    collaborator INDUSTRY

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Carol Mathews, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565145 on ClinicalTrials.gov