PB125, Osteoarthritis, Pain, Mobility, and Energetics

Stopped early · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Knee, Muscle Weakness, Pain, Joint

In brief

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.

Key facts

Study ID

NCT04638387

Run by

Colorado State University

People needed

4

Starts

2020-11-03

Expected to finish

2021-09-01

Last updated by the study team

2022-09-14

Who can join

Age: 50 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• bilateral knee osteoarthritis

You may not qualify if…

• smoking
• pregnant/breastfeeding
• BMI >30
• known liver, renal, heart disease, diabetes, autoimmune disease, cancer
• use of methotrexate, etanercept, infliximab, leflunomide, plaquenil
• recent serious illness
• intraarticular stem cell injection
• intraarticular steroid or hyaluronic acid injection within 4 months
• current enrollment in another trial of investigational drugs
• known hypersensitivity to ashwagandha, luteolin, rosemary, or rice flour
• use of anticoagulants or known bleeding disorder
• unwillingness to comply with protocol
• plans for knee replacement in the next 3 years
• unable to complete mobility testing without ambulatory aid
• unable to climb 1-2 flights or stairs without stopping/shortness of breath/discomfort
• blood product transfusion within 30 days
• unable to provide legal consent

Where it is running

• Colorado State University — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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