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.

J Med Food. 2018 May;21(5):511-520. doi: 10.1089/jmf.2017.0065. Epub 2018 Apr 30. Karlapudi V1, Prasad Mungara AVV2, Sengupta K3, Davis BA4, Raychaudhuri SP5. Author information 1 1 Pujitha Hospital , Vijayawada, India . 2 2 Vijaya Super Speciality Hospital , SPSR Nellore, India . 3 3 Laila Nutraceuticals R&D Center , Vijayawada, India . 4 4 PLT Health Solutions, Inc. , Morristown, New Jersey, USA. 5 5 Department of Medicine, School of Medicine, University of California Davis , Davis, California, USA. 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. KEYWORDS: Boswellia serrata; Curcuma longa; T. chebula; osteoarthritis PMID: 29708818 DOI: 10.1089/jmf.2017.0065 [Indexed for MEDLINE]