Effects of Pau d' Arco in Primary Dysmenorrhea

Completed · Early Phase 1

Conditions studied: Primary Dysmenorrhea

In brief

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.

Key facts

Study ID

NCT04245540

Run by

National University of Natural Medicine

People needed

12

Starts

2019-07-30

Expected to finish

2022-12-15

Last updated by the study team

2023-03-24

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Biologically female
• Ages 18-45
• Presence of primary dysmenorrhea
• Has a 'smart' phone and is willing to download and use an electronic application for use during the study.
• Willing to take a non-hormonal form of birth control throughout the trial period (abstinence, condom, diaphragm, or copper IUD (ParaGard))
• Lives in the Portland area
• Able to speak, read and write English
• Has reliable transportation to clinic
• Willing to have four fasting blood draws taken
• Wiling to collect menstrual fluid in a Diva© cup on the first day of menstruation and ability to deliver it to the clinic on the same day
• Ability to receive and complete electronic VAS scales
• Pain scale rating of 6 or higher on the VAS scale
• Monthly pain that correlates with menstruation

You may not qualify if…

• Presence of secondary dysmenorrhea
• General health measures outside of normal range:
• Blood pressure readings obtained at the Screening Visit reveal hypotension (≤90/60 mmHg) or hypertension (≥140/90 mmHg).
• Aspartate aminotransferase (AST) < 8 U/L or > 48 U/L at the Screening Visit.
• Alanine aminotransferase (AST) < 7 U/L or > 55 U/L at the Screening Visit.
• Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 at the Screening Visit.
• An INR value > 1.1 at the Screening Visit.
• A red blood cell count < 3.90 million cells/mcL or > 5.03 million cells/mcL.
• A hemoglobin value of < 12 g/dL (120 g/L) or > 15.5 g/dL (155 g/L).
• A hematocrit value of < 34.9% or > 44.5%.
• A white blood cell count < 3.5 billion cells/L (3,500 cells/mcL) or > 10.5 billion cells/L (10,500 cells/mcL)
• A platelet count < 150 billion/L (150,000/mcL) or > 450 billion/L (450,000 mcL).
• Women who are nursing, pregnant, or planning pregnancy in the next four months
• Difficulty swallowing or aversion to capsules, tablets, or pills
• Currently taking, and unwilling to discontinue, NSAIDs (Aspirin, Ibuprofen)
• Currently taking dietary supplements with any of the following ingredients in amounts over 250 mg/day: cinnamon, garlic, ginger, turmeric, and/or curcumin
• Consumption of >1 alcoholic drink per day, during the study period
• Currently taking any anticoagulation medications (Warfarin/Coumadin)
• Currently taking, or have taken in the past two months, hormonal forms of birth control
• Unwillingness, or inability, to take a monthly pregnancy test during the timeline of the study (3 pregnancy tests)
• Past or present medical history of any of the following:
• Blood clotting disorders (von Willebrand disease, Hemophilia A, Hemophilia B, etc.)
• Liver disease (cirrhosis, hepatitis, liver failure, jaundice, liver cancer, etc.)
• Kidney disease (chronic kidney disease, polycystic kidney disease, etc.)
• Cardiac disease (hypertension, heart failure, cardiomyopathy, etc.)

Where it is running

• National University of Natural Medicine — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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