Effects of Pau d' Arco in Primary Dysmenorrhea

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participants needed

12
sponsor

National University of Natural Medicine

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Updated on 19 February 2024

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fasting

dysmenorrhea

copper

paragard

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.

Description

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.

Details

Condition	Primary Dysmenorrhea
Age	18-45 years
Treatment	Pau d' Arco
Clinical Study Identifier	NCT04245540
Sponsor	National University of Natural Medicine
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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Effects of Pau d' Arco in Primary Dysmenorrhea