Effects of Pau d' Arco in Primary Dysmenorrhea (EPAPD)

This is an interventional other trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, dysmenorrhea, tabebuia avellanedae, tabebuia impetiginosa, pau d' arco, taheebo bark, menstrual pain, pelvic pain, menstrual cramps, painful menstruation, menstrual distress, herbal medicine, phytomedicine, complementary therapy, complementary medicine, alternative therapy, alternative medicine, traditional medicine, plant extracts, supplement Read More

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