effects of pau d' arco in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

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.

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.

Eligibility criteria:
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) \ 48 u/l at the screening visit. * alanine aminotransferase (ast) \ 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 \ 5.03 million cells/mcl. * a hemoglobin value of \ 15.5 g/dl (155 g/l). * a hematocrit value of \ 44.5%. * a white blood cell count \ 10.5 billion cells/l (10,500 cells/mcl) * a platelet count \ 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

Keywords: 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