Effects of Pau d' Arco in Primary Dysmenorrhea
Effects of Pau d' Arco in Primary Dysmenorrhea
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.
This is a single arm, open-label trial evaluating safety and tolerability of 1,050 mg/day of
 encapsulated Tabebuia avellanedae every day for 2 months, as well as effects of the treatment
 on quality of life, pain intensity, and pain interference, in 12 generally healthy women aged
 18-45 with PDM. Outcomes of this study include questionnaires to evaluate: safety and
 tolerability using standardized adverse events scales (primary); participant reported
 measurements of quality of life, pain intensity, and pain interference around menses
 collected on validated instruments (secondary); and blood concentration of PGE2 and
 high-sensitivity C-reactive protein (tertiary). The protocol followed the SPIRIT guidelines
 and fulfilled the SPIRIT checklist.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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.)

 -  Anemia (iron deficiency, sickle cell, aplastic, etc.)

 -  Inflammatory bowel disease

 -  Irritable bowel syndrome

 -  Endometriosis

 -  Obstructive endometrial polyps

 -  Chronic pelvic inflammatory disease

 -  Polycystic Ovarian Syndrome

 -  Adenomyosis

 -  Intrauterine or pelvic adhesions

 -  Congenital obstructive mullerian malformations

 -  Cervical stenosis

 -  Use of an intrauterine contraceptive device that causes pain

 -  Pelvic congestion syndrome

 -  Reproductive cancer (uterine cancer, ovarian cancer, endometrial cancer, etc.)

 -  Ovarian cysts

 -  Fibroids

 -  Uteropelvic junction obstruction