Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04638387 · ClinicalTrials.gov registry record · NA
PB125, Osteoarthritis, Pain, Mobility, and Energetics
A NA study, sponsored by Colorado State University.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04638387 is a NA study that was terminated before completion, run by Colorado State University. The registered enrollment target is 4 participants.
The verdict
NCT04638387, a NA study, was terminated before completion, sponsored by Colorado State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
Nuclear factor erythroid 2-related factor 2 (Nrf2) is an important regulator in the body. It controls how well cells protect themselves against stress. PB125 (Pathways Bioscience) is a plant based activator of this important regulator Nrf2. PB125 is made up of three plant extracts (rosemary, ashwagandha, and Sophora japonica) so that it contains these things; 1. Carnosol, 2. Withaferin A, and 3. Luteolin. Carnosol comes from rosemary leaves. Rosemary is a spice often used in Italian foods and grown in many herb gardens all around Fort Collins. Withaferin A comes from the medicinal plant Withania somnifera, also called ashwagandha. Ashwaganda is commonly known as "Indian Winter cherry" or "Indian Ginseng" and it is one of the most important herbs of Ayurveda (the traditional system of medicine in India) used for millennia. Finally, luteolin is found widely in plants including those present in the diet (peppers, onions, celery, herbs/spices). Some people purchase these herbs commercially, and take them on their own for a variety of purposes. Typically, when you buy them, they will be in much higher doses than they are in PB125. What makes PB125 different is that very low doses of each of the 3 components work together-synergistically-to activate Nrf2 and increase the ability of cells to respond to stress. It is unknown if there are any benefits to taking PB125 and the risks are currently unknown. The purpose of this study is to examine changes in muscle, in joint pain, in mobility (standing and walking) and in leg strength that occur after consuming PB125 every day for 3 months. We want to make these measurements in people who have been diagnosed with mild to moderate osteoarthritis-a degenerative joint disease-in their knees.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT PB125
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2021-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04638387
The ClinicalTrials.gov registry entry for NCT04638387 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Colorado State University, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04638387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04638387 about?
NCT04638387 is a clinical study titled "PB125, Osteoarthritis, Pain, Mobility, and Energetics". Nuclear factor erythroid 2-related factor 2 (Nrf2) is an important regulator in the body. It controls how well cells protect themselves against stress. PB125 (Pathways Bioscience) is a plant based activator of this important regulator Nrf2. PB125 is made up of three plant extracts (rosemary, ashwaga...
What is the current status of trial NCT04638387?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2020-11-03. Estimated completion is 2021-09-01.
What interventions are being tested in trial NCT04638387?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), PB125 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04638387?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.