Vedic Lifesciences, a contract research organization based, has completed a randomized, controlled dose response study for Interpath Pty Ltd. on its patented ingredient called Epiitalis.
Vedic Lifesciences (Mumbai, India), a contract research organization based, has completed a randomized, controlled dose response study1 for Interpath Pty Ltd. (Ballarat, VIC, Australia) on its patented ingredient called Epiitalis. A hydrolyzed oil extract of the Biota orientalis seed, Epiitalis was shown to help reduce symptoms of knee osteoarthritis in subjects.
In the study, 223 subjects between the ages of 40 and 65 diagnosed with knee osteoarthritis and knee pain greater than 60 on a 100 point visual analog scale (VAS) were randomized into four groups to receive either 640 mg of Epiitalis, 320 mg of Epiitalis, 160 mg of Epiitalis, or a matched placebo, daily for 56 days. The primary outcome of the study was the change in VAS scores from baseline to 56 days. Exploratory outcomes included the mWOMAC (modified Western Ontario and McMaster Universities Arthritis Index), and the SF-36 QoL (quality of life) questionnaire. Researchers also calculated the The OMERACT-OARSI (Outcome Measures in Arthritis Clinical Trials–Osteoarthritis Research Society International) responder index was also calculated.
Results showed that compared to placebo, all doses of Epiitalis produced significant changes in VAS scores, and led to beneficial changes in the mWOMAC, SF-36, and OMERACT-OARSI responder index. Additionally, no adverse events were recorded during the trial as a result of taking Epiitalis. Additional trials with lower doses will be necessary for researchers to establish a clear dose response.