A Placebo-Controlled Double-Blind Study Demonstrates the Clinical Efficacy of a Novel Herbal Formulation for Relieving Joint Discomfort in Human Subjects with Osteoarthritis of Knee
Publication: Journal of Medicinal Food
Volume 21, Issue Number 5
Abstract
LI73014F2 is a novel composition prepared from extracts of Terminalia chebula fruit, Curcuma longa rhizome, and Boswellia serrata gum resin with synergistic benefit in 5-Lipoxygenase (5-LOX) inhibition. This herbal composition with strong anti-5-LOX activity exhibited significant pain relief as indicated through improvements in weight-bearing capacity in a monosodium iodoacetate-induced osteoarthritis (OA) model of Sprague–Dawley rats. A 90-day randomized, placebo-controlled double-blind study evaluates the clinical efficacy and tolerability of LI73014F2 in the management of symptoms of OA of the knee (Clinical Trial Registration No. CTRI/2014/01/004338). Subjects, (n = 105), were randomized into three groups: placebo (n = 35), 200 mg/day of LI73014F2 (n = 35), and 400 mg/day of LI73014F2 (n = 35). All study participants were evaluated for pain and physical function by using standard tools, that is, Visual Analog Scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the baseline (day 0) and on day 14 ± 3, 30 ± 3, 60 ± 3, and at the end of the study (day 90 ± 3). In addition, routine examinations on biochemical parameters in serum, urine, and hematological parameters were conducted on each visit to assess the safety of the study material. At the end of the trial period, LI73014F2 conferred significant pain relief, improved physical function, and quality of life in OA patients. In conclusion, preclinical and clinical data together strongly suggest that the herbal formulation LI73014F2 is a safe and effective intervention for management of joint discomfort, demonstrating efficacy as early as 14 days.
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Information & Authors
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Copyright 2018, Mary Ann Liebert, Inc. and Korean Society of Food Science and Nutrition.
History
Published in print: May 2018
Published online: 1 May 2018
Published ahead of print: 30 April 2018
Accepted: 5 November 2017
Received: 4 May 2017
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Author Disclosure Statement
V.K. and A.V.V.P.M. are employees of Pujitha Hospital, Vijayawada, India and Vijaya Super Speciality Hospital, Nellore, India, respectively. K.S. is an employee of Laila Nutraceuticals, Vijayawada, India. B.A.D. and S.P.R. are employees of PLT Health Solutions, Inc., NJ, USA and University of California Davis, CA, USA, respectively.
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