A Single Arm, Open-label Pilot Trial Examining the Effects of Pau d' Arco on Primary Dysmenorrhea in Reproductive Age Women
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Red Blood Cell Count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Uteropelvic junction obstruction
结局指标
主要结局
Red Blood Cell Count
时间窗: Mean change in 4 weeks RBC count to 8 weeks.
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
时间窗: Mean change in 4 weeks Hemoglobin g/dL to 8 weeks.
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
时间窗: Mean change in 4 weeks Hematocrit % to 8 weeks.
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
时间窗: Mean change in 4 weeks MCV fL to 8 weeks.
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
时间窗: Mean change in 4 weeks MCH pg to 8 weeks.
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
时间窗: Mean change in 4 weeks MCH pg to 8 weeks.
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 and retention.
时间窗: Percent change from Baseline Recruitment to 8 weeks.
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.
Incidence of Intervention-attributable Adverse Events
时间窗: Percent from 4 weeks Intervention-attributable Adverse Events to 8 weeks.
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 (AST)
时间窗: Mean change in 4 weeks AST values at 8 weeks.
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 (ALT)
时间窗: Mean change in 4 weeks ALT values at 8 weeks.
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."
Estimated glomerular filtration rate (eGFR)
时间窗: Mean change in 4 weeks eGFR value at 8 weeks.
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.
International normalized ratio
时间窗: Mean change in 4 weeks INR value at 8 weeks.
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.
Systolic Blood pressure
时间窗: Mean change from 4 weeks systolic blood pressure at 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).
Diastolic Blood pressure
时间窗: Mean change from 4 weeks diastolic blood pressure at 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).
次要结局
- Anxiety Subscore Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Anxiety Score and 8 weeks.)
- Depression Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Depression Score and 8 weeks.)
- Fatigue Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Fatigue Score and 8 weeks.)
- Pain Interference Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Pain Interference Score and 8 weeks.)
- Sleep Disturbance Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Sleep Disturbance Score and 8 weeks.)
- Physical Functioning Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Physical Functioning Score and 8 weeks.)
- Social Role Subscore of the Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)(Mean change in Baseline Social Role Score and 8 weeks.)
- Visual Analog Scale (VAS)(Mean change in 4 weeks VAS Score and 8 weeks.)
- Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function Measure(Mean change in Baseline PROMIS Sexual Function Score and 8 weeks.)