Ayuric® Hyperuricemia Study Published
FOR IMMEDIATE RELEASE
A NEW CLINICAL STUDY IN SUBJECTS WITH HYPERURICEMIA, published in the PubMed listed journal Clinical Pharmacology: Advances and Applications, shows Natreon’s Ayuric® (standardized aqueous extract of Terminalia bellerica) can significantly decrease serum uric acid levels.
New Brunswick, NJ, June 23, 2016 – Natreon’s Ayuric®, a clinically studied and standardized aqueous extract of Terminalia bellerica, significantly reduced serum uric acid levels in subjects with hyperuricemia according to a clinical study just published in Clinical Pharmacology: Advances and Applications. Asymptomatic hyperuricemia is common and serum uric acid levels greater than 10 mg/dL may lead to symptoms of gout. Gout is a form of inflammatory arthritis that is caused by hyperuricemia and can lead to the deposition of uric acid crystals in tissues and fluids within the body. Hyperuricemia is caused by an overproduction or under excretion of uric acid, and is not only a risk factor for renal disease progression, but may also affect patient survival by inducing or aggravating cardiovascular disease. The prevalence of gout among adults in the U.S. was 3.9% in 2007-2008 (8.3 million individuals) with men being affected more than women. Due to the increasing prevalence of gout and the adverse effects associated with prescription gout medications, consumers are searching for a natural alternative to help lower serum uric acid levels.
This randomized, double-blind, placebo-controlled study evaluated the effects of Ayuric®, a natural xanthine oxidase inhibitor, and the prescription gout medication febuxostat on uric acid levels in subjects with hyperuricemia. Subjects were randomized to receive Ayuric® 250 mg twice daily, 500 mg twice daily, febuxostat 40 mg once daily (with a placebo dose given in the evening), and placebo for 24 weeks. The primary outcome measure of the study was the absolute change in serum uric acid levels from baseline to the end of 24 weeks of treatment. Secondary outcome measures included the percentage of subjects whose serum uric acid levels have decreased to < 6.0mg/dL and measurements of tolerability following treatment at the end of 24 weeks. A total of 88 subjects completed the study. At the end of 24 weeks, the mean percentage decrease in serum uric acid levels with Ayuric® was dose dependent at 28% in the 500 mg group (p<0.001) and 14% in the 250 mg group, while febuxostat decreased uric acid levels by 48%. The reduction in serum uric acid levels in the Ayuric® group was observed as early as 4 weeks after starting therapy and maximum results were seen after 4 months. With the placebo group, there was in fact an increase of 7% in uric acid levels.
The percentage of subjects who achieved the target serum uric acid level ≤ 6 mg/dL at the end of 24 weeks was the secondary outcome measure. All the subjects in the febuxostat group achieved the target serum uric acid level, whereas 88% of the Ayuric® 500 mg group reached this target. Measurement of tolerability was assessed at the end of 24 weeks as “Good” because no serious side effects were observed in either of the study groups. However, two subjects in the febuxostat group had mildly elevated bilirubin levels and one subject reported nausea and vomiting. There were no reports of adverse effects in the Ayuric® treatment groups. Due to its positive safety profile, and ability to decrease serum uric acid levels, Ayuric® may be a good choice for preventing gout attacks, especially in subjects who may be at higher risk for gastrointestinal or renal complications from the current prescription gout medications.
Natreon, Inc. is continuing its commitment to research and development with additional controlled clinical studies to evaluate the analgesic efficacy and safety of Ayuric®.
The full study is available at: https://www.dovepress.com/a-randomized-double-blind-placebo–and-positive-controlled-clinical-pi-peer-reviewed-article-CPAA
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 www.natreoninc.com.
Natreon, Inc. Key Employees:
Dr. Sanni Raju – CEO/Chairman
Lucien Hernandez – Senior VP Sales and Marketing
Jeff Lind – VP Sales and Marketing
Dr. Aparna Kalidindi – Manager, Technical Sales and Marketing
Nicole Stirling – Account Executive