International Journal of Medical Sciences

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23 October 2017

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Int J Med Sci 2011; 8(7):615-622. doi:10.7150/ijms.8.615

Research Paper

A Double Blind, Randomized, Placebo Controlled Clinical Study Evaluates the Early Efficacy of Aflapin® in Subjects with Osteoarthritis of Knee

Amar A. Vishal1, Artatrana Mishra2, Siba P Raychaudhuri3 ✉

1. Department of Orthopedics, Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), National Highway 5, Eluru, 534 002, India
2. Department of Internal Medicine, Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), National High way 5, Eluru, 534 002 India
3. Department of Medicine, Division of Rheumatology, Allergy and Immunology, School of Medicine, U C Davis and VA Medical Center Sacramento, Hospital Way, Mather, California 95655, USA

Abstract

Aflapin® is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin® and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin® in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin® or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA.

Keywords: Aflapin, Clinical study, Boswellia serrata, Osteoarthritis, Visual Analog Scale

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How to cite this article:
Vishal AA, Mishra A, Raychaudhuri SP. A Double Blind, Randomized, Placebo Controlled Clinical Study Evaluates the Early Efficacy of Aflapin® in Subjects with Osteoarthritis of Knee. Int J Med Sci 2011; 8(7):615-622. doi:10.7150/ijms.8.615. Available from http://www.medsci.org/v08p0615.htm