OXIS International, Inc., today announced highly favorable final results from an initial clinical study to assess the beneficial effects of its patent-pending ERGOFLEX™ joint health formula, launched commercially in December 2010. Specifically, the study found that reduction of pain was statistically significant after as little as one week of ERGOFLEX use. Similar improvements were seen with range of motion. Benefits continued during the six weeks subjects took ERGOFLEX, and for some the benefits persisted during the subsequent six-week washout period.
ERGOFLEX is the only joint health complex containing the powerful antioxidant L-Ergothioneine (ERGO) and is specifically formulated to help the body fight the pain of joint inflammation and maintain optimal joint health. It is the first in a series of products built around the ERGO platform that are planned by OXIS.
"These powerful and statistically significant final results strongly suggest that ERGOFLEX can provide significant quick and lasting relief from mild-to-moderate joint pain while improving range of motion, which results in an improved quality of life," said Bernie Landes, President of OXIS International. "These clinically demonstrated results represent an important breakthrough for those tens of millions of Americans who suffer with chronic joint pain and diminished range of motion. While most joint pain products only address the symptoms, ERGOFLEX targets and relieves oxidative stress, which frequently is the underlying cause of joint ailments. It also provides a suite of extensively researched natural ingredients that help maintain the structural integrity of joints and relieve pain."
The study included 12 subjects taking ERGOFLEX at the recommended dose of two capsules per-day for six weeks, followed by a six-week washout period. At study start the participants exhibited mild-to-moderate chronic pain affecting range of motion in several areas, including neck, shoulders, arms, lower back, hips and knees. The participants also had not consumed other joint relief supplements or juices with high antioxidant content for a period of two months prior to study intake.
Subjects were examined in the lab at study start (day 0) and at weeks one, six and 12; in addition, questionnaires were conducted weekly via phone to monitor health changes. Each subject was evaluated using 27 distinct range-of-motion measurements conducted on the major areas of discomfort and on the body's entire vertical axis. The assessments were performed by Dr. David Ager, DC at Cascade Spine and Rehabilitation clinic, using the J-Tech dual digital inclinometry. All 12 subjects completed the 12-week study.
Based on the results from this initial trial, OXIS plans to design and implement a placebo-controlled, randomized clinical trial with ERGOFLEX.
OXIS has previously announced the First World Congress on Ergothioneine to be held at UCLA in July 2011. This study reflects OXIS's continuing commitment to building its business on a foundation of sound science.