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Natreon, Inc.: 2016 Science of Ingredients

AIDP

2-D Janine Pl.
New Brunswick, NJ 08901
Phone: (732) 296-1080 • Fax: (732) 296-1075
Email: info@natreoninc.com
Website: www.natreoninc.com

AyuFlex: A Vegetarian and Organic Product for Joint Health

Osteoarthritis (OA) is one of the most common forms of arthritis and is the leading cause of disability in American adults. Commonly affected joints include the finger, knee, hip, spine and metatarsophalangeal joints of the foot. The goals of treatment in osteoarthritis include resolution of symptoms, prevention or reduction in disease progression, and improvement of functional ability. These goals can be accomplished with non-pharmacologic and pharmacologic therapies.1

There are several different pharmacologic therapies, including acetaminophen and oral NSAIDs, which are most commonly used. Acetaminophen is commonly used due to its relative safety profile; however, reports of acetaminophen-induced hepatotoxicity have increased in recent years. Oral NSAIDs, such as ibuprofen and naproxen, are recommended as initial therapy in more moderate to severe cases of OA.1 Patient-related factors should be considered prior to initiating oral NSAIDs due to the adverse risks associated with these medications, including gastrointestinal toxicity, kidney impairment and cardiovascular risks.1

Natreon’s AyuFlex is a clinically proven, water-soluble, vegetarian, organic, non-GMO (genetically modified organism) product for joint health. It is derived from edible fruits of Terminalia chebula, an ancient ayurvedic plant, and standardized to high levels of bioactives.2 The main mechanism of action appears to be via inhibition of COX-1, COX-2 and 5-LOX enzymes.3 It has been used in India for thousands of years for its anti-inflammatory and analgesic effects without the adverse effects that are associated with acetaminophen and NSAIDs.2 In one randomized, double-blind, placebo-controlled trial, patients with osteoarthritis for at least six months duration and meeting the ARA functional class I to III with radiological evidence were randomized to receive AyuFlex 250 mg twice daily, AyuFlex 500 mg twice daily, or placebo.2 This was a 12-week trial which assessed WOMAC scores, knee swelling index, and VAS (visual analog scale) for pain, stiffness and disability. Patients were allowed to use acetaminophen as a rescue medication. Results from this study showed that patients with osteoarthritis taking AyuFlex had a significant reduction in WOMAC scores, knee swelling index, and VAS-pain, VAS-stiffness, and VAS-disability.

Of note, patients taking AyuFlex used significantly less rescue medication (paracetamol) compared to the placebo group. In regards to safety, all renal, hematologic, and hepatic parameters were within normal limits in the treatment group. GI (gastrointestinal) adverse effects, such as dyspepsia and diarrhea were the most commonly reported in the treatment group (n = 3). AyuFlex was well tolerated and no serious adverse events were observed during this study.2 In addition to the study in moderately osteoarthritic patients, there are two randomized, double-blind placebo controlled crossover studies that were completed to examine the analgesic activity of AyuFlex in healthy human volunteers. In these studies, subjects were given a single 1000 mg dose of AyuFlex and subjected to a hot air pain model or a mechanical pain model. Both force and time for pain threshold and pain tolerance from both these studies were statistically significant at p < 0.001 compared to placebo.4-5

OA is one of the leading causes of disability in the United States. Due to adverse effects associated with traditional treatments of OA, such as oral NSAIDs and acetaminophen, patients are turning to dietary/herbal supplements. AyuFlex, which is derived from the ancient ayurvedic plant Terminalia chebula, is an optimal choice for joint health. AyuFlex is standardized to pharmaceutical quality and recent studies have shown significant reductions in mWOMAC scores, knee swelling index, and VAS-pain, stiffness, and disability scales. In addition, only three patients experienced mild adverse effects (diarrhea and dyspepsia) during treatment with AyuFlex and no subjects discontinued the study due to adverse events. Thus, AyuFlex, a vegetarian, organic, non-GMO and water-soluble product is a safe and effective supplement for joint health support.

References:

1 Arthritis Foundation. Osteoarthritis Fact Sheet. 2013.

2 Pingali UR et al. A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to evaluate the analgesic effect of Terminalia chebula, Crominex, and their combination in subjects with Osteoarthritis (Pending publication).

3 Reddy et al. Chebulagic acid, a COX-LOX dual inhibitor isolated from the fruits of Terminalia chebula Retz., induces apoptosis in COLO-205 Cell Line. Journal of Ethnopharmacology 124 (2009) 506-512.

4 Pokuri VK, et al. A Randomized, Double Blind, Placebo Controlled, Cross Over Study to evaluate analgesic activity of Terminalia chebula in healthy human participants using mechanical pain model. (Pending publication).

5 Kumar UC, et al. Evaluation of Analgesic Activity of Terminalia Chebula in Healthy Human Participants Using Hot Air Pain Model – A Randomized, Double Blind, Placebo Controlled, Cross Over Study. The Journal of Clinical and Diagnostic Research. 2015. 9(5):FC01-FC04.