AflaB2® and osteoarthritis: a multicentric, observational, post-marketing surveillance study in Indian patients suffering from knee osteoarthritis


  • Atul V. Jain Department of Orthopaedics, Elite Bone Care and Gynae Cosmetic Surgery Center, Delhi, India
  • Karun A. Jain Department of Orthopaedics, Shree Mahaveer Ortho Clinic, Delhi, India
  • N. Vijayaraghavan Department of Orthopaedics, Radiance Clinics, Chennai, India



Aflapin®, Native collagen type II, AflaB2®, Osteoarthritis, Oral tolerization, 5-LOX


Background: Osteoarthritis (OA) is one of the most debilitating chronic degenerative joint disorder characterized by pain, inflammation and stiffness of joints with wear and tear of the cartilage. Recent evidences suggest the involvement of the immune pathway in OA development. This study was conducted to evaluate the efficacy and safety of AflaB2® capsules containing Aflapin® and native collagen type II in knee OA patients.

Methods: Total 40 knee OA subjects were enrolled at the out-patient department (OPD) of three different sites under supervision of physicians as per the inclusion and exclusion criteria of the study. Subjects were instructed to consume AflaB2® capsules once daily orally for three months. They were informed to visit the respective study center as per the schedule visits to assess and record the efficacy and safety.

Results: AflaB2® treatment showed significant reduction in pain and stiffness with improvement in physical functions compared to the baseline. The reduction in pain score was observed from 2nd visit on visual analogue scale (VAS). The VAS score was reduced to 1.63±1.23 (p<0.001) from its baseline score 6.0±1.04 at the end of the treatment. The WOMAC Total Score was reduced to 18.1±6.04 (p<0.001) from its baseline score 74.4±8.07 at the end of the treatment. The improvement was observed in WOMAC pain, stiffness and physical functions score. No significant side-effect was reported with AflaB2® treatment throughout the study.

Conclusions: The present study provides the evidence in support of the potential efficacy and excellent tolerability of oral intake of AflaB2® capsules in reducing OA symptoms.


Roemer FW, Demehri S, Omoumi P, Link TM, Kijowski R, Saarakkala S et al. State of the Art: Imaging of Osteoarthritis-Revisited 2020. Radiol. 2020;296(1):5-21

Chow YY, Chin KY. The Role of Inflammation in the Pathogenesis of Osteoarthritis. Mediators Inflamm. 2020; 2020:8293921.

Primorac D, Molnar M, Rod E, Jeleč Z, Čukelj F, Matišić V et al. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020;11(8):854.

Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020;72(2):149-62.

Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskeletal Dis. 2013;5(2):77-94.

Yuan GH, Masuko-Hongo K, Kato T, Nishioka K. Immunologic intervention in the pathogenesis of osteoarthritis. Arthritis Rheum. 2003;48(3):602-11.

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):615-22.

Sengupta K, Kolla JN, Krishnaraju AV, Yalamanchili N, Rao CV, Golakoti T et al. Cellular and molecular mechanisms of anti-inflammatory effect of Aflapin: a novel Boswellia serrata extract. Mol Cell Biochem. 2011;354(1-2):189-97.

Krishnaraju AV, Sundararaju D, Vamsikrishna U, Suryachandra R, Machiraju G, Sengupta K et al. Safety and toxicological evaluation of Aflapin: a novel Boswellia-derived anti-inflammatory product. Toxicol Mech Methods. 2010;20(9):556-63.

Park KS, Park MJ, Cho ML, Kwok SK, Ju JH, Ko HJ et al. Type II collagen oral tolerance; mechanism and role in collagen-induced arthritis and rheumatoid arthritis. Mod Rheumatol. 2009;19(6):581-9.

Scarpellini M, Lurati A, Vignati G, Marrazza MG, Telese F, Re K et al. Biomarkers, type II collagen, glucosamine and chondroitin sulfate in osteoarthritis follow-up: the "Magenta osteoarthritis study". J Orthop Traumatol. 2008;9(2):81-7.

Maldonado M, Nam J. The role of changes in extracellular matrix of cartilage in the presence of inflammation on the pathology of osteoarthritis. Biomed Res Int. 2013;2013:284873.

Attur M, Dave M, Abramson SB, Amin A. Activation of diverse eicosanoid pathways in osteoarthritic cartilage: a lipidomic and genomic analysis. Bull NYU Hosp Jt Dis. 2012;70(2):99-108.

He Wendy, Pelletier JP, Martel-Pelletier J, Laufer S, Battista JAD. Synthesis of interleukin 1beta, tumor necrosis factor-alpha, and interstitial collagenase (MMP-1) is eicosanoid dependent in human osteoarthritis synovial membrane explants: interactions with anti-inflammatory cytokines. J Rheumatol. 2002;29(3):546-53.

Kurokouchi K, Kambe F, Yasukawa K, Izumi R, Ishiguro N, Iwata H et al. TNF-alpha increases expression of IL-6 and ICAM-1 genes through activation of NF-kappaB in osteoblast-like ROS17/2.8 cells. J Bone Miner Res. 1998;13(8):1290-9.

Martel-Pelletier J, Wildi LM, Pelletier JP. Future therapeutics for osteoarthritis. Bone. 2012;51(2):297-311.

Sengupta K, Krishnaraju AV, Vishal AA, Mishra A, Trimurtulu G, Sarma KVS et al. Comparative efficacy and tolerability of 5-Loxin and Aflapin Against osteoarthritis of the knee: a double blind, randomized, placebo controlled clinical study. Int J Med Sci. 2010;7(6):366-77.

Rudrappa GH, Chakravarthi PT, Benny IR. Efficacy of high-dissolution turmeric-sesame formulation for pain relief in adult subjects with acute musculoskeletal pain compared to acetaminophen: A randomized controlled study. Med (Baltimore). 2020;99(28):e20373.

Kulkarni PD, Damle ND, Singh S, Yadav KS, Ghante MR, Bhaskar VH et al. Double-blind trial of solid lipid Boswellia serrata particles (SLBSP) vs. standardized Boswellia serrata gum extract (BSE) for osteoarthritis of knee. Drug Metabol Pers Ther. 2020;2020:104.

Italiano G, Raimondo M, Giannetti G, Gargiulo A. Benefits of a Food Supplement Containing Boswellia serrata and Bromelain for Improving the Quality of Life in Patients with Osteoarthritis: A Pilot Study. J Altern Complement Med. 2020;26(2):123-9.

Majeed M, Majeed S, Narayanan NK, Nagabhushanam K. A pilot, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee. Phytother Res. 2019;33(5):1457-68.

Feragalli B, Ippolito E, Dugall M, Cacchio M, Belcaro G, Cesarone MR et al. Effectiveness of a novel boswellic acids delivery form (Casperome®) in the management of grade II ankle sprains due to sport trauma - a registry study. Eur Rev Med Pharmacol Sci. 2017;21(20):4726-32.

Pinzon RT, Wijaya VO. Curcuma longa and Boswellia Serrata for improving functional status in osteoarthritis patients: From bench to bedside evidences. Asian J Med Sci. 2019;10(5):1-5.

Vaishya R, Agarwal AK, Shah A, Vijay V, Vaish A. Current status of top 10 nutraceuticals used for Knee Osteoarthritis in India. J Clin Orthop Trauma. 2018;9(4):338-48.

Bakilan F, Armagan O, Ozgen M, Tascioglu F, Bolluk O, Alatas O. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial. Eurasian J Med. 2016;48(2):95-101.






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