Testing Kava and Kratom Herbal Supplement against a placebo for anxiety

Exclusion

• −Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
• −Use of anxiolytic or sleep aids (natural health products or drugs) in the 4 weeks before baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
• −Demonstrates a positive urine drug screen test for compounds listed in Table 9 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → or Baseline visits, a positive urine cotinine test at the Screening or Baseline visits, or a positive breath alcohol test at Baseline visit.
• −Have abnormal RR or SpO2 measurements at Screening or Baseline at the discretion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• −Screening laboratory results showing liver enzyme levels \[Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), Gamma-Glutamyl Transferase (GGT), total bilirubin\] ≥ 2 times the upper limit of normal, or any other clinically significant abnormal safety laboratory values as per the Investigator's discretion.
• −Is currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → or has received/used an investigational product in another research study within 28 days before baseline.
• −Individuals with an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
• −Have Type I/Type II diabetes or thyroid disease (thyroid function to be assessed by TSH, T3, and T4 levels at Screening visit).
• −High BP at the Screening or Baseline Visit (≥140 systolic or ≥90 diastolic mmHg)
• −Have low BP (\<90 systolic or \<60 diastolic mmHg) at Baseline unless deemed clinically insignificant by the investigator and the participant is asymptomatic.
• −Have a history of heart disease, blood clotting disorders, renal or hepatic impairment/disease, or liver injury.
• −Have known genetic polymorphisms of CYP450, CYP3A4, CYP2D6, and/or CYP1A2 enzymes.
• −Individuals with active asthma or have experienced an asthma attack in the last 5 years.
• −Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
• −Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years before the screening visit.
• −Reports significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days before baseline or a blood donation of more than 450 mL within 56 days before baseline.
• −Reports donating plasma (e.g., plasmapheresis) within 15 days before baseline.
• −History of alcohol or substance abuse (e.g., opioids, kratom) (including having been hospitalized for such an in-patient or out-patient intervention program).
• −Evidence of addictive tendency as indicated by an LDQ score ≥21.
• −Currently consumes more than two (2) standard alcoholic beverages per day on average for 4 weeks.
• −Note: A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
• −Excessive caffeine intake, defined as habitual consumption of \>500 mg per day.
• −Any other medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures, pose a significant risk to the participant or compromise the quality of study data.
• −Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
• −Major surgery in 3 months before screening or planned major surgery during the study.