Research article

A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin^® for treatment of osteoarthritis of the knee

Krishanu Sengupta¹ , Krishnaraju V Alluri² , Andey Rama Satish³ , Simanchala Mishra⁴ , Trimurtulu Golakoti⁵ , Kadainti VS Sarma⁶ , Dipak Dey⁷ and Siba P Raychaudhuri⁸

¹Cellular and Molecular Biology Division, Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, 520 007 India

²Pharmacology Division, Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, 520 007 India

³Department of Orthopedics, Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), National Highway 5, Eluru, 534 002 India

⁴Department of Internal Medicine, Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), National High way 5, Eluru, 534 002 India

⁵Drug Discovery and Development Division, Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, 520 007 India

⁶Department of Statistics, Prakasam Road, SV University, Tirupati, 517 592 India

⁷Department of Statistics, 215 Glenbrook Road, University of Connecticut, Storrs, Connecticut 06269, USA

⁸Department 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

author email corresponding author email

Arthritis Research & Therapy 2008, 10:R85doi:10.1186/ar2461

Published:	30 July 2008

See related editorial by Dougados, http://arthritis-research.com/content/10/5/116

Abstract

Introduction

5-Loxin^® is a novel Boswellia serrata extract enriched with 30% 3-O-acetyl-11-keto-beta-boswellic acid (AKBA), which exhibits potential anti-inflammatory properties by inhibiting the 5-lipoxygenase enzyme. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the efficacy and safety of 5-Loxin^® in the treatment of osteoarthritis (OA) of the knee.

Methods

Seventy-five OA patients were included in the study. The patients received either 100 mg (n = 25) or 250 mg (n = 25) of 5-Loxin^® daily or a placebo (n = 25) for 90 days. Each patient 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 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients. Measurement of a battery of biochemical parameters in serum and haematological parameters, and urine analysis were performed to evaluate the safety of 5-Loxin^® in OA patients.

Results

Seventy patients completed the study. At the end of the study, both doses of 5-Loxin^® conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients. Interestingly, significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin^® as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, we also noted significant reduction in synovial fluid matrix metalloproteinase-3. In comparison with placebo, the safety parameters were almost unchanged in the treatment groups.

Conclusion

5-Loxin^® reduces pain and improves physical functioning significantly in OA patients; and it is safe for human consumption. 5-Loxin^® may exert its beneficial effects by controlling inflammatory responses through reducing proinflammatory modulators, and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients.

Trail Registration

(Clinical trial registration number: ISRCTN05212803.)