CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Kava Dietary Supplement +1 moredrug
Likely dose
Kava Dietary Supplement 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04565145
NCT04565145Phase 2Completed
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A Phased Clinical Trial of a Dietary Supplement Kava: Biomarker Changes and Anxiolytic Effects Phase 2: Kava Biomarker

University of Florida·interventional·Posted Sep 25, 2020·Updated Aug 13, 2024

In Brief

A Phase 2 clinical trial evaluating Kava Dietary Supplement and Placebo for Pharmacokinetics. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
CollaboratorsThorne HealthTech, Inc, National Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 25, 2020
Enrollment StartApr 5, 2021
Primary CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago

Interventions

Kava Dietary Supplementdrug

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

Placebodrug

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