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

Primary Dysmenorrhea

Participants must have the ability to menstruate to participate in the current study.

Pau d' Arco

National University of Natural Medicine

Effects of Pau d' Arco in Primary Dysmenorrhea

A Single Arm, Open-label Pilot Trial Examining the Effects of Pau d' Arco on Primary Dysmenorrhea in Reproductive Age Women

Red blood cell count will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 3.80-5.10 Million/uL. Red blood cell (RBC) count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study. This measure will be reported as: "Number of participants with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."

Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL). Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."

Hemoglobin is a protein in red blood cells that carries oxygen throughout the body. Hemoglobin will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 11.7-15.5 grams per deciliter (g/dL. Hemoglobin of less than 11.7 g/dL or greater than 15.5 g/dL will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemoglobin levels" and "Number of participants with abnormal Hemoglobin values."

Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Hematocrit will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 35.0-45.0 %. Hemoglobin of less than 35.0% or greater than 45.0% will be considered as abnormal. This measure will be reported as: "Number of participants with normal Hemotocrit % levels" and "Number of participants with abnormal Hematocrit % values."

Mean Corpuscular Volume (MCV) measures the average red blood cell volume. MCV will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 80.0-100.0 femtolitre (fL). MCV of less than 80.0 fL or greater than 100.0 fL will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCV fL levels" and "Number of participants with abnormal MCV fL values."

Mean Corpuscular Hemoglobin (MCH) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."

Mean Corpuscular Hemoglobin Concentration (MCHC) measures the average mass of hemoglobin per red blood cell. MCH will be collected through a Complete Blood Count (CBC) test. Normal ranges for this test are 27.0-33.0 picogram (pg). MCH of less than 27.0 pg or greater than 33.0 pg will be considered as abnormal. This measure will be reported as: "Number of participants with normal MCH pg levels" and "Number of participants with abnormal MCH pg values."

Recruitment of 12 women with primary dysmenorrhea and retention of at least 10 participants throughout the course of the study. Reported as number of recruited participants, number of excluded participants, and number of drop out participants.

Self-reported adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Reported as: New onset "FDA serious" adverse events; New onset "moderate" adverse events; all reported adverse events

Aspartate aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 10-30 U/L. Any participant with a value of 2 times or higher of the upper end of this range (60 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal AST levels," "Number of participants with abnormal AST values," and "Number of participants withdrawn from the study based on elevated AST values."

Alanine aminotransferase is an enzyme that is often measured in blood as an indication of liver toxicity. This value is reported as cubic rack units (U) per liter (L); (U/L). Normal ranges are 6-29 U/L. Any participant with a value of 2 times or higher of the upper end of this range (58 U/L or greater) will be withdrawn from the study per study stopping criteria. This value will be reported as: "Number of participants with normal ALT levels," "Number of participants with abnormal ALT values," and "Number of participants withdrawn from the study based on elevated ALT values."

Glomerular filtration rate is estimated based on blood creatinine concentration per standard nephrology practice. This value is reported as milliliters/minute/1.73m2 (mL/min/1.73m2). An eGFR value is considered normal if it is 60 or greater mL/min/1.73m2, and abnormal if it is less than 60 mL/min/1.73m2. Results will be reported as normal (60 or greater mL/min/1.73m2) or abnormal (less than 60 mL/min/1.73m2). Participants will be withdrawn from the study if two consecutive readings of eGFR show a decrease in eGFR of 15 mL/min/1.73m2 or greater.

Prothrombin time (PT) measures the ability of the blood to form blood clots through hemostasis. Partial thromboplastin time (PTT) also assess the ability to form blood clots through hemostasis, as well as amount and functions of proteins that initiate the clotting process (coagulation factors). PT and PTT will be combined to calculate the International Normalized Ratio (INR). INR is a calculation based on PT and PTT that measures the ability to form blood clots. INR values are dimensionless and will be reported numerically. A value less than 2.0 is considered normal. Any values of 2.0 or greater are considered abnormal and will result in exclusion from the study. If 25% or more of the study participants have INR values of 2.0 or greater at any point during the study period, the study will end and all participants will be withdrawn. Reported as numerical values of INR, percent of participants withdrawn from the study based on INR values of 2.0 or greater, and study stopping criteria.

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Systolic pressure will be assessed during the study period. Reported as: hypotension (less than 90 mmHg), normal blood pressure (90-139 mmHg), or hypertension (140 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of systolic blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 4 weeks).

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (Baseline and 8 weeks).

Blood pressure is used to assess hemodynamic stability by measuring the pressure of circulating blood on the walls of blood vessels. Diastolic pressure will be assessed during the study period. Reported as: hypotension (less than 60 mmHg), normal blood pressure (60-89 mmHg), or hypertension (90 or greater mmHg). 2 consecutive readings of hypotension or hypertension will results in withdrawal from the study. Readings of blood pressure from participants who complete the study will be reported in a table showing both systolic and diastolic readings at each time point assessed (4 weeks and 8 weeks).

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The anxiety subscale score ranges from 4-20, with a higher score indicating higher anxiety and a lower score indicating lower anxiety. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The depression subscale score ranges from 4-20, with a higher score indicating more depression and a lower score indicating less depression. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The fatigue subscale score ranges from 4-20, with a higher score indicating more fatigue and a lower score indicating less fatigue. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The pain interference subscale score ranges from 4-20, with a higher score indicating more pain interference and a lower score indicating less pain interference. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The sleep disturbance subscale score ranges from 4-20, with a higher score indicating more sleep disturbance and a lower score indicating less sleep disturbance. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The physical functioning subscale score ranges from 4-20, with a higher score indicating more physical function and a lower score indicating less physical function. Reported as a subscale.

The Patient Reported Outcomes Measurement Information System 29 (PROMIS-29) measures is a survey designed to measure self-reported physical, mental, and social health and wellbeing. This survey consists of 7 subscale scores, including: symptom-oriented subscores (anxiety, depression, fatigue, pain interference, and sleep disturbance) and function-oriented domains (physical functioning and social role). The social role subscale score ranges from 4-20, with a higher score indicating more ability to participate in social roles and activities and a lower score indicating less ability to participate in social roles and activities. Reported as a subscale.

The Visual Analog Scale (VAS) is a psychometric response scale used to measure the intensity of pain. Pain is a subjective measure and pain intensity is used to quantify how much a person believes they are in pain. This scale ranges from 0-10, with lower scores indicating less subjective pain and higher scores indicating more subjective pain. This will be reported as change in a numerical value.

The Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measure measures sexual function and evaluation of sexual experiences over the past 30 days. It is a subjective measure with 10 questions. These include domains such as: interest in sexual activity, lubrication during sexual activity, physical comfort during sexual activity, physical pain during sexual activity, orgasm during sexual activity, and overall satisfaction with sexual activity. This measure is scored using the HealthMeasures Scoring Device, with higher scores indicating better sexual function and lower scores indicating worse sexual function.

hs-CRP measures tissue inflammation and injury. This measure is used in standard cardiac practices to assess risk of cardiovascular disease, inflammation, and injury. This value is reported as milligrams per liter (mg/L). A value of less than 3 mg/L indicates average risk of cardiovascular disease and inflammation and a value of 3 mg/L or greater indicates an increased risk of cardiovascular disease and inflammation. This will be reported as "Number of participants with normal risk of cardiovascular disease and inflammation," "Number of participants with higher risk of cardiovascular disease and inflammation," "Change in number of participants with higher risk of cardiovascular disease and inflammation to lower risk of cardiovascular disease and inflammation," and "Change in number of participants with normal risk of cardiovascular disease and inflammation to higher risk of cardiovascular disease and inflammation, reported as a percentage."

Prostaglandins are a group of hormone-like substances that act as a principal mediator of inflammation in diseases and in menstruation. Changes in the level of prostaglandins directly correlate with the amount of pain that may be subjectively experienced. The normal range of this value is 200-400 picograms per milliliter (pg/mL). This will be reported as: "Number of participants with normal prostaglandin levels," "Number of participants with elevated prostaglandin levels," "Number of participants with decreased prostaglandin values," "Number of participants whose prostaglandin levels decreased," and "Number of participants whose prostaglandin levels increased."

tabebuia chrysotricha/dismenoreja

Effects of Pau d' Arco in Primary Dysmenorrhea

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