Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia

Criteria

Inclusion Criteria:- adult (at least 18 years of age);

• diagnosed with knee osteoarthritis (OA) ;

• body mass index (BMI) of less than 40;

• willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;

• willing and able to monitor blood glucose levels if diabetic;

• willing to abstain from caffeine-containing drinks and food before coming into a study visit;

• able to read and understand English and have the cognitive capacity to give consent;

• willing to abstain from use of the following during participation in the study:

prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, Advil, Motrin, Nuprin, Naproxen, etc.); any dietary supplements (St. John's Wort, etc.); and, grapefruit and/or products containing it.

Exclusion Criteria:- cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (CABG), arrhythmia, high or low blood pressure;

• recurrent stomach upset, or gastric or duodenal ulcers;

• gallstones or gall bladder disease (cholelithiasis);

• liver or kidney disease;

• alcohol use of more than two drinks per day on a regular basis;

• Coumadin or anti-platelet drug use;

• at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome;

• pregnant or breast feeding, or intention to become pregnant during the study;

• pronounced allergies, or known allergy to study product or corn starch (placebo);

• have had an injection to treat OA within the past three months;

• currently taking NSAIDs, unless they are willing to stop for a 1-week wash-out period;

• currently on a selective serotonin reuptake inhibitor (SSRI) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and,

• reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., NSAIDs), and any dietary supplements; grapefruit and/or its products; and, St. John's Wort.