Effects of Pau d' Arco in Primary Dysmenorrhea

NCT04245540 | Completed Early Phase 1 FDA Drug

• 1 other identifier: RB11617
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea

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

Outcome Measures

Primary Outcomes (38)

• Red Blood Cell Count

  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count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study.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with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."

  Mean change in Screening RBC count to 4 weeks.

• Red Blood Cell Count

  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count of less than 3.80 Million/uL will be considered as new onset anemia and will result in the participant being withdrawn from the study.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with normal RBC count levels," "Number of participants with abnormal RBC count values," and "Number of participants withdrawn from the study based on decreased RBC count values."

  Mean change in Screening RBC count to 8 weeks.

• Red Blood Cell Count

  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."

  Mean change in 4 weeks RBC count to 8 weeks.

• Hemoglobin

  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."

  Mean change in Screening Hemoglobin g/dL to 4 weeks.

• Hemoglobin

  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."

  Mean change in Screening Hemoglobin g/dL to 8 weeks.

• Hemoglobin

  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."

  Mean change in 4 weeks Hemoglobin g/dL to 8 weeks.

• Hematocrit

  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 change in Screening Hematocrit % to 4 weeks.

• Hematocrit

  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 change in Screening Hematocrit % to 8 weeks.

• Hematocrit

  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 change in 4 weeks Hematocrit % to 8 weeks.

• Mean Corpuscular Volume

  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 change in Screening MCV fL to 4 weeks.

• Mean Corpuscular Volume

  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 change in Screening MCV fL to 8 weeks.

• Mean Corpuscular Volume

  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 change in 4 weeks MCV fL to 8 weeks.

• Mean Corpuscular Hemoglobin

  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 change in Screening MCH pg to 4 weeks.

• Mean Corpuscular Hemoglobin

  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 change in Screening MCH pg to 8 weeks.

• Mean Corpuscular Hemoglobin

  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 change in 4 weeks MCH pg to 8 weeks.

• Mean Corpuscular Hemoglobin Concentration

  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."

  Mean change in 4 weeks MCH pg to 8 weeks.

• Recruitment and retention.

  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.

  Percent change from Baseline Recruitment to 8 weeks.

• Incidence of Intervention-attributable Adverse Events

  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

  Percent change from Baseline Intervention-attributable Adverse Events to 4 weeks.

• Incidence of Intervention-attributable Adverse Events

  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

  Percent change from Baseline Intervention-attributable Adverse Events to 8 weeks.

• Incidence of Intervention-attributable Adverse Events

  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

  Percent from 4 weeks Intervention-attributable Adverse Events to 8 weeks.

• Aspartate aminotransferase (AST)

  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."

  Mean change in Screening AST values at 4 weeks.

• Aspartate aminotransferase (AST)

  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."

  Mean change in Screening AST values at 8 weeks.

• Aspartate aminotransferase (AST)

  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."

  Mean change in 4 weeks AST values at 8 weeks.

• Alanine aminotransferase (ALT)

  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."

  Mean change in Screening ALT values at 4 weeks.

• Alanine aminotransferase (ALT)

  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."

  Mean change in Screening ALT values at 8 weeks.

• Alanine aminotransferase (ALT)

  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."

  Mean change in 4 weeks ALT values at 8 weeks.

• Estimated glomerular filtration rate (eGFR)

  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.

  Mean change in Screening eGFR value at 4 weeks.

• Estimated glomerular filtration rate (eGFR)

  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.

  Mean change in Screening eGFR value at 8 weeks.

• Estimated glomerular filtration rate (eGFR)

  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.

  Mean change in 4 weeks eGFR value at 8 weeks.

• International normalized ratio

  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.

  Mean change in Screening INR value at 4 weeks.

• International normalized ratio

  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.

  Mean change in Screening INR value at 8 weeks.

• International normalized ratio

  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.

  Mean change in 4 weeks INR value at 8 weeks.

• Systolic Blood pressure

  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).

  Mean change from Baseline systolic blood pressure at 4 weeks.

• Systolic Blood pressure

  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).

  Mean change from Baseline systolic blood pressure at 8 weeks.

• Systolic Blood pressure

  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).

  Mean change from 4 weeks systolic blood pressure at 8 weeks.

• Diastolic Blood pressure

  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).

  Mean change from Baseline diastolic blood pressure at 4 weeks.

• Diastolic Blood pressure

  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).

  Mean change from Baseline diastolic blood pressure at 8 weeks.

• Diastolic Blood pressure

  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).

  Mean change from 4 weeks diastolic blood pressure at 8 weeks.

Secondary Outcomes (11)

• 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.

Other Outcomes (2)

• High sensitivity C-reactive protein (hs-CRP)

  Mean change in Baseline hs-CRP and 8 weeks.

• Prostaglandins

  Mean change in Baseline prostaglandin levels and 8 weeks

Study Arms (1)

Active

EXPERIMENTAL

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

Dietary Supplement: Pau d' Arco

Interventions

Pau d' Arco DIETARY_SUPPLEMENT

Encapsulated herbal Pau d' Arco.

Active

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants must have the ability to menstruate to participate in the current study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

Location

Related Publications (12)

• Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

  PMID: 16690671 BACKGROUND

• Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.

  PMID: 24695505 BACKGROUND

• Zahradnik HP, Hanjalic-Beck A, Groth K. Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review. Contraception. 2010 Mar;81(3):185-96. doi: 10.1016/j.contraception.2009.09.014. Epub 2009 Nov 6.

  PMID: 20159173 BACKGROUND

• Halter F, Tarnawski AS, Schmassmann A, Peskar BM. Cyclooxygenase 2-implications on maintenance of gastric mucosal integrity and ulcer healing: controversial issues and perspectives. Gut. 2001 Sep;49(3):443-53. doi: 10.1136/gut.49.3.443.

  PMID: 11511570 BACKGROUND

• Lee JH, Cheong J, Park YM, Choi YH. Down-regulation of cyclooxygenase-2 and telomerase activity by beta-lapachone in human prostate carcinoma cells. Pharmacol Res. 2005 Jun;51(6):553-60. doi: 10.1016/j.phrs.2005.02.004.

  PMID: 15829436 BACKGROUND

• Twardowschy A, Freitas CS, Baggio CH, Mayer B, dos Santos AC, Pizzolatti MG, Zacarias AA, dos Santos EP, Otuki MF, Marques MC. Antiulcerogenic activity of bark extract of Tabebuia avellanedae, Lorentz ex Griseb. J Ethnopharmacol. 2008 Aug 13;118(3):455-9. doi: 10.1016/j.jep.2008.05.013. Epub 2008 May 18.

  PMID: 18579323 BACKGROUND

• Pereira IT, Burci LM, da Silva LM, Baggio CH, Heller M, Micke GA, Pizzolatti MG, Marques MC, Werner MF. Antiulcer effect of bark extract of Tabebuia avellanedae: activation of cell proliferation in gastric mucosa during the healing process. Phytother Res. 2013 Jul;27(7):1067-73. doi: 10.1002/ptr.4835. Epub 2012 Sep 12.

  PMID: 22969019 BACKGROUND

• Giacomelli I, Scartoni D, Fiammetta M, Baki M, Zei G, Muntoni C, Cappelli S, Greto D, Scoccianti S, Livi L. Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer. Nutr Cancer. 2015;67(8):1247-53. doi: 10.1080/01635581.2015.1082114. Epub 2015 Oct 9.

  PMID: 26451712 BACKGROUND

• Lee MH, Choi HM, Hahm DH, Her E, Yang HI, Yoo MC, Kim KS. Analgesic and anti-inflammatory effects in animal models of an ethanolic extract of Taheebo, the inner bark of Tabebuia avellanedae. Mol Med Rep. 2012 Oct;6(4):791-6. doi: 10.3892/mmr.2012.989. Epub 2012 Jul 17.

  PMID: 22825254 BACKGROUND

• de Miranda FG, Vilar JC, Alves IA, Cavalcanti SC, Antoniolli AR. Antinociceptive and antiedematogenic properties and acute toxicity of Tabebuia avellanedae Lor. ex Griseb. inner bark aqueous extract. BMC Pharmacol. 2001;1:6. doi: 10.1186/1471-2210-1-6. Epub 2001 Sep 13.

  PMID: 11574048 BACKGROUND

• Lira AA, Sester EA, Carvalho AL, Strattmann RR, Albuquerque MM, Wanderley AG, Santana DP. Development of lapachol topical formulation: anti-inflammatory study of a selected formulation. AAPS PharmSciTech. 2008;9(1):163-8. doi: 10.1208/s12249-007-9002-z. Epub 2008 Jan 25.

  PMID: 18446477 BACKGROUND

• de Almeida ER, da Silva Filho AA, dos Santos ER, Lopes CA. Antiinflammatory action of lapachol. J Ethnopharmacol. 1990 May;29(2):239-41. doi: 10.1016/0378-8741(90)90061-w. No abstract available.

  PMID: 2374436 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Pelvic Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ryan Bradley, ND, MPH

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, open-label trial evaluating safety and tolerability.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: January 29, 2020
• Study Start: July 30, 2019
• Primary Completion: January 1, 2022
• Study Completion: December 15, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)