A NEW JOINT HEALTH CLINICAL STUDY published in the PubMed listed, Elsevier publication, Asian Journal of Pharmaceutical and Clinical Research, shows Natreon’s AyuFlex® (standardized aqueous extract of Terminalia chebula) can significantly improve joint discomfort.
New Brunswick – Natreon’s AyuFlex®, a clinically studied and standardized aqueous extract of Terminalia chebula, significantly improves joint discomfort according to a human clinical study just published in The Asian Journal of Pharmaceutical and Clinical Research. AyuFlex® is a GRAS-affirmed and patented ingredient for joint health and pain relief. Osteoarthritis (OA) is one of the most common forms of arthritis and is the leading cause of disability in American adults. It is a chronic condition that is known to affect weight-bearing and other moveable joints. In the United States, an estimated 27 million people older than 25 years have clinical OA. Traditionally, NSAIDs have been the mainstay of treatment for acute and chronic pain conditions, including osteoarthritis. However, the risks of gastrointestinal toxicity and renal impairment have led to the search for alternative analgesics with fewer adverse effects, such as Terminalia chebula.
In this randomized, double blind, placebo controlled study, a total of 100 healthy human volunteers suffering from joint discomfort for at least 6 months were randomized into five treatment groups: AyuFlex® 500 mg twice daily, AyuFlex® 500 mg twice daily + Proprietary Chromium Complex (PCC) 400 μg once daily, PCC 400 μg once daily alone, placebo, and AyuFlex® 250 mg twice daily for 12 weeks. Proprietary Chromium Complex (PCC) was added to the study because in a previous clinical study at Murray State University in Kentucky, this compound significantly improved joint discomfort in dogs, and its efficacy in humans needed to to be evaluated. Assessment of symptoms of knee joint pain and discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI). Visual analog scale (VAS) was also used for subjective assessment of pain, stiffness, and disability. Results from this study showed that treatment with AyuFlex® 500 mg twice daily for 12 weeks resulted in significant improvements in mWOMAC scores compared to placebo (36% reduction vs. 4.52% in placebo; p < 0.001), knee swelling index ( p < 0.001 vs. placebo), and VAS pain, stiffness, and disability (p < 0.001 for all categories vs. placebo). The therapeutic benefit was evident in as short as 4 weeks. In addition, the number of rescue medications (acetaminophen) used by subjects was the least in the AyuFlex® 500 mg twice daily group. This supports the analgesic efficacy of AyuFlex®. The response seems to have a linear relationship with dose. In regards to safety, all the study medications were well tolerated and no serious adverse events were reported. No subjects dropped out of the study and all laboratory parameters were within normal limits at the end of the study. Due to its positive safety profile, and ability to improve joint discomfort, AyuFlex® may be a good choice for acute or chronic painful ailments, especially in patients who may be at higher risk for gastrointestinal or renal complications.
Natreon, Inc. is continuing its commitment to research and development with additional controlled clinical studies to evaluate the analgesic efficacy and safety of AyuFlex®.
The full study is available at: http://innovareacademics.in/journals/index.php/ajpcr/article/view/11217/5078
About Natreon Inc.
Natreon Inc. is a 17 year old company located in New Jersey with a state of the art R&D facility in Kolkata, India, and is focused on developing and marketing Ayurvedic products backed by extensive research, high degree of standardization, multiple clinical studies, safety studies, and intellectual property. Natreon’s R&D team is headed by Prof. Shibnath Ghosal, a Fulbright scholar and an eminent natural product chemist with hundreds of publications in scientific journals and a group of Ph.D. and Master’s level scientists. Natreon’s scientific research includes process optimization, development of chromatographic analytical methods such as HPLC, HPTLC, GC-MS and LC-MS for standardization, development of marker compounds, and pharmacological studies. Safety studies are done in the USA and clinical studies are conducted in reputed institutes in India as well as the USA.
For more information on AyuFlex® and Natreon’s other patented ingredients, please visit Natreon.
