Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract
- Conditions
- Osteoarthritis, Knee
- Interventions
- Drug: Enteric coated Devil's ClawDrug: Non-enteric coated Devil's Claw
- Registration Number
- NCT03641248
- Lead Sponsor
- University of Missouri-Columbia
- Brief 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.
- Detailed Description
The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enteric coated Devil's Claw Enteric coated Devil's Claw H. procumbens 100 mg in enteric coated capsules Non-enteric coated Devil's Claw Non-enteric coated Devil's Claw H. procumbens 100 mg in non-enteric coated capsules
- Primary Outcome Measures
Name Time Method Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml) 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours Blood will be drawn at predefined intervals following administration of one dose of study drug
Time to reach Cmax (h) 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours Blood will be drawn at predefined intervals following administration of one dose of study drug
Determination of terminal half-life of Devil's Claw, t 1/2 (h) 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours Blood will be drawn at predefined intervals following administration of one dose of study drug
- Secondary Outcome Measures
Name Time Method Change in plasma levels of harpagide 24 hours after dose of Devil's Claw Blood will be drawn for Devil's Claws metabolites at Visit 2
Change in levels of 8-p-coumarylharpagide 24 hours after dose of Devil's Claw Blood will be drawn for Devil's Claws metabolites at Visit 2
Change in plasma levels of verbascoside 24 hours after dose of Devil's Claw Blood will be drawn for Devil's Claws metabolites at Visit 2
Change in plasma levels of harpagoside 24 hours after dose of Devil's Claw Blood will be drawn for Devil's Claws metabolites at Visit 2
Trial Locations
- Locations (1)
Univ of Missouri Health Care Center
🇺🇸Columbia, Missouri, United States