Osteoarthritis, Knee
Conditions
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.
Interventions
DRUGEnteric coated Devil's Claw
Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
DRUGNon-enteric coated Devil's Claw
Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Pharmacokinetic
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 harpagide | 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 |
Countries
United States
Outcome results
None listed