Real world evidence of effectiveness and safety of an oral formulation containing un-denatured type-II collagen 40 mg and aflapin 100 mg (HAPID®) in the management of osteoarthritis of knee: findings of a prospective, multi-center, observational study


  • A. K. Pal Baksi Orthopedic Trauma and Rehabilition, India
  • Sanjoy Sen B. P. Poddar Hospital and Medical Research, India
  • Sanatan Behera Sanatan Spine and Orthopedic Clinic, India
  • Rajeev Anand Sun Hospital, India Anand Nursing Home, India
  • Chandrachur Bhattacharyya G. D. Hospital And Diabetes Institute, India
  • K. Kalidoss K. M. Hospital, India
  • Arumugam S. Bharathirajaa Speciality Hospital, India
  • Shivarajaiah . Namratha Orthopedic Center, India
  • P. C. Jagadeesh JOSS Center, India
  • Sagar Karvir AYUSH Nursing Home, India
  • J. C. Patil Adarsh Nursing Home, India
  • Rajeev Anand Anand Nursing Home, India
  • Jawahar Jethwah Orthopedic Hospital, Dr. Jawahar Jethwa, India
  • Ashok Suryavanshi Marina Grand Hospital, India
  • H. J. Sangtani Ortho Relief Hospital and Research Center, India
  • Sameer Jadhwar Medical Affair, Wockhardt Ltd, Mumbai, Maharashtra, India
  • Khokan Debnath Medical Affair, Wockhardt Ltd, Mumbai, Maharashtra, India
  • Atul Panghate Center For Bone and Joint Disease, India
  • Pradeep Moonot Mumbai Knee Foot Ankle Clinic, Mumbai, India



Osteoarthritis, Aflapin, Type-II collagen, Boswellia serrata


Background: Osteoarthritis (OA) of knee is a common progressive multifactorial joint disorder affecting the quality of life, and surgical repair is the final option which has substantial impact on healthcare costs. This real-world study evaluates the efficacy and safety of an oral formulation containing UC-II and aflapin (Boswellia serrata extract enriched in 3-O-acetyl-11-keto-beta-boswellic acid) for treatment of OA of knee.

Methods: Data of 505 ambulatory adult patients (study duration-Jul-21 to Jul-22) of either gender (227 M, 278 F) having OA of knee, and who received study treatment (capsule HAPID®, Wockhardt, India) once daily for a period of up to 90 days were included for the study after obtaining informed written consent. Primary outcomes were mean change in Western Ontario and McMaster universities OA index (WOMAC) scores from baseline through day 90 (total and sub-scales for joint pain, joint stiffness, and physical function), and change in 0-10 visual analogue scale (VAS) score for pain.

Results: About 285 (56.4%) patients were newly diagnosed, majority (63.4%) were having grade 2 severity of OA (Kellgren and Lawrence grade). The mean (SD) baseline total WOMAC scores improved from 60.94 (23.60) at baseline to 26.42 (22.19) on day 90. Significant improvements were seen starting from day 5 (p=0.023) and progressively up to day 90 (p<0.0001).

Conclusions: The excellent safety and efficacy profile of combination therapy with aflapin and UC-II makes it a desirable pharmacological treatment modality for management of patients of knee OA.


Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019;393(10182):1745-59.

GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545-602.

Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies? E Clin Med. 2020;29-30:100587.

Thati S. Gender Differences in Osteoarthritis of Knee: An Indian Perspective. J Midlife Health. 2021;12(1):16-20.

Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016;50(5):518-522.

Nadkar MY, Samant RS, Vaidya SS, Borges NE. Relationship between osteoarthritis of knee and menopause. J Assoc Physicians India. 1999;47(12):1161-3.

Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99.

Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16(4):494-502.

Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995;38(8):1134-41.

Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578-89.

Oo WM, Yu SP, Daniel MS, Hunter DJ. Disease-modifying drugs in osteoarthritis: current understanding and future therapeutics. Expert Opin Emerg Drugs. 2018;23(4):331-347.

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.

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

Paul C, Leser S, Oesser S. Significant Amounts of Functional Collagen Peptides Can Be Incorporated in the Diet While Maintaining Indispensable Amino Acid Balance. Nutrients. 2019;11(5):1079.

Trentham DE, Dynesius-Trentham RA, Orav EJ, Combitchi D, Lorenzo C, Sewell KL et al. Effects of oral administration of type II collagen on rheumatoid arthritis. Science. 1993;261(5129):1727-30.

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833-40.

Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990;20(3-1):42-50.

Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99.

Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010;18(1):24-33.

Abdel-Tawab M, Werz O, Schubert-Zsilavecz M. Boswellia serrata: an overall assessment of in vitro, preclinical, pharmacokinetic and clinical data. Clin Pharmacokinet. 2011;50(6):349-69.

Anazodo MI, Subramanian LR, Ammon HP. Boswellic acids: novel, specific, nonredox inhibitors of 5-lipoxygenase. J Pharmacol Exp Ther. 1992;261(3):1143-6.

Bagi CM, Berryman ER, Teo S, Lane NE. Oral administration of undenatured native chicken type II collagen (UC-II) diminished deterioration of articular cartilage in a rat model of osteoarthritis (OA). Osteoarthritis Cartilage. 2017;25(12):2080-90.

Barnett ML, Kremer JM, St Clair EW, Clegg DO, Furst D, Weisman M et al. Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 1998;41(2):290-7.

Bagchi D, Misner B, Bagchi M, Kothari SC, Downs BW, Fafard RD et al. Effects of orally administered undenatured type II collagen against arthritic inflammatory diseases: a mechanistic exploration. Int J Clin Pharmacol Res. 2002;22(3-4):101-10.

Mobasheri A, Mahmoudian A, Kalvaityte U, Uzieliene I, Larder CE, Iskandar MM et al. A White Paper on Collagen Hydrolyzates and Ultrahydrolyzates: Potential Supplements to Support Joint Health in Osteoarthritis? Curr Rheumatol Rep. 2021;23(11):78.

Lugo JP, Saiyed ZM, Lane NE. Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study. Nutr J. 2016;15:14.

Crowley DC, Lau FC, Sharma P, Evans M, Guthrie N, Bagchi M et al. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci. 2009;6(6):312-21.

Sengupta K, Krishnaraju AV, Vishal AA, Mishra A, Trimurtulu G, Sarma KV 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.

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.






Original Research Articles