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Effects of Pau d' Arco in Primary Dysmenorrhea

NCT04245540 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-03-24

No results posted yet for this study

Summary

A single arm, open-label trial evaluating safety and tolerability of encapsulated Tabebuia avellanedae in 12 generally healthy women aged 18-45 with primary dysmenorrhea (PDM). This will be the first study evaluating the safety and tolerability of Tabebuia avellanedae in PDM. We also aim to collect proof-of-concept mechanistic data supporting the hypothesis that Tabebuia avellanedae reduces PGE2 concentration in vivo in women with PDM.

Conditions

  • Primary Dysmenorrhea

Interventions

DIETARY_SUPPLEMENT

Pau d' Arco

Encapsulated herbal Pau d' Arco.

Sponsors & Collaborators

  • National University of Natural Medicine

    lead OTHER

Principal Investigators

  • Ryan Bradley, ND, MPH · National University of Natural Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2022-01-01
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04245540 on ClinicalTrials.gov