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

National University of Natural Medicine (NUNM)

Status and phase: Completed; Early Phase 1

Conditions: Primary Dysmenorrhea

Treatments: Dietary Supplement: Pau d' Arco

Study type: Interventional

Funder types: Other

Identifiers

NCT04245540

RB11617

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Active

Experimental group

Description:

1,050 mg per day of encapsulated Pau d' Arco taken orally for 2 months.

Treatment:

Dietary Supplement: Pau d' Arco