A non-interventional, prospective, multicentric real life Indian study to assess safety and effectiveness of un-denatured type 2 collagen in management of osteoarthritis


  • Apurv Mehra Max Superspecialty Hospital and Institute of Joint Replacement, Patparganj, Delhi, India
  • Pankaj Anand Pentamed Hospital, New Delhi, India
  • Mangesh Borate Borate Hospital, Hadpsar, Pune, Maharashtra, India
  • Prasenjit Paul IQ City Medical College, Durgapur, West Bengal, India
  • Sanjay Kamble Department of Medical Affairs, Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Kapil Dev Mehta Department of Medical Affairs,Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Amit Qamra Department of Medical Affairs,Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Agam Shah Department of Clinical Operations, Wockhardt Ltd., BKC, Mumbai, Maharashtra, India
  • Rishi Jain Department of Medical Affairs,Wockhardt Ltd., BKC, Mumbai, Maharashtra, India




Osteoarthritis, Undenatured collagen, Efficacy, Safety, India


Background: Osteoarthritis (OA) is the most common musculoskeletal condition affecting the quality of life. Undenatured collagen type II has emerged as one of the promising treatment options in treatment of OA. Despite being available in India, clinical safety and efficacy have not been evaluated. We performed a non-interventional, real-life study to determine its safety and efficacy in Indian population.

Methods: A non-interventional, real-life study was performed in patients with OA of knee by 18 orthopaedicians in India. Patients enrolled were followed-up at day 30 (visit 2), day 60 (visit 3) and day 90 (visit 4). Efficacy was assessed by Western Ontario McMaster Osteoarthritis Index (WOMAC) and Visual Analogue scale (VAS) on each visit. Safety was assessed by incidence of suspected adverse events (AEs), and abnormal laboratory parameters.

Results: Among 291 enrolled patients 226 patients completed the study. Mean age of the population was 56.2±8.7 years and 53.3% of them were females. In 291 patients included in safety analysis, at least one treatment emergent adverse event (TEAE) was seen in 4.47% patients. None of the AEs were serious or resulted in termination of patient from the study. Nausea (1.37%) and headache (1.03%) were the common AEs. Treatment with undenatured collagen type II was associated with significant reduction in WOMAC score (p<0.0001) and VAS scores (p<0.0001) from baseline to day 90.

Conclusions: Undenatured collagen type II is safe and efficacious in Indian patients with OA. This can be considered early in the initial management of OA.


Barbour KE, Helmick CG, Boring M, Brady TJ. Vital Signs: Prevalence of Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation-United States, 2013-2015. Morbidity and Mortality Weekly Report. 2017;66:246-53.

Akhter E, Bilal S, Haque U. Prevalence of arthritis in India and Pakistan: A review. Rheumatol Int. 2011;31:849-55.

Pal C, Singh P, Chaturvedi S, Pruthi K, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016;50:518-22.

Chnadra D, Rastogi A. Osteoarthrtitis. Abvailable from https://www.nhp.gov.in/disease/musculo-skeletal-bone-joints-/osteoarthritis. Accessed on 16 February 2017.

Farr II J, Miller LE, Block JE. Quality of Life in Patients with Knee Osteoarthritis: A Commentary on Nonsurgical and Surgical Treatments. The Open Orthop J. 2013;7:619-23.

Kawano MM, Araújo ILA, Castro MC, Matos MA. Assessment of quality of life in patients with knee osteoarthritis. Acta Ortopédica Bras. 2015;23:307-10.

Al-Shidhani A, Al-Rawahi N, Al-Rawahi A, Murthi PS. Non-steroidal anti-inflammatory drugs (NSAIDs) use in primary health care centers in A’Seeb, Muscat: A clinical audit. Oman Med J. 2015;30:366-71.

Yusuf E. Pharmacologic and Non-Pharmacologic Treatment of Osteoarthritis. Curr Treat Options Rheumatol. 2016;2:111-25.

Sharma AR, Jagga S, Lee SS, Nam JS. Interplay between cartilage and subchondral bone contributing to pathogenesis of osteoarthritis. Int J Mol Sci. 2013;14:19805-30.

Scanzello CR. Role of low-grade inflammation in osteoarthritis. Curr Opin Rheumatol. 2017;29:79–85.

Robinson WH, Lepus CM, Wang Q, Raghu H, Mao R, Lindstrom TM, Sokolove J. Low-grade inflammation as a key mediator of the pathogenesis of osteoarthritis. Nature Rev Rheumatol. 2016;12:580-92.

Bagchi D, Misner B, Bagchi M, Kothari SC, Downs BW, Preuss HG. Effects of orally administered undenatured type II collagen against arthritic inflammatory diseases: a mechanistic exploration. Int J Clin Pharmacol Res. 2002;22:101-10.

Prabhoo R, Billa G. Undenatured collagen type II for the treatment of osteoarthritis: A review. Int J Res Orthop. 2018;4:684-9.

Lugo JP, Saiyed ZM, Lau FC, Molina JP, Pakdaman MN, Shamie AN, et al. Undenatured type II collagen (UC-II®) for joint support: A randomized, double-blind, placebo-controlled study in healthy volunteers. J Int Soc Sports Nutr. 2013;10:48.

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;6:312-21.

Amoako AO, Pujalte GGA. Osteoarthritis in Young, Active, and Athletic Individuals. Clin Med Insights: Arthritis Musculoskelet Disord. 2014;7:27-32.

Hanna FS, Teichtahl AJ, Wluka AE, Wang Y, Urquhart DM, English DR, et al. Women have increased rates of cartilage loss and progression of cartilage defects at the knee than men: A gender study of adults without clinical knee osteoarthritis. Menopause. 2009;16:666-70.

Boyan BD, Tosi LL, Coutts RD, Enoka RM, Hart DA, Nicolella DP, et al. Addressing the gaps: Sex differences in osteoarthritis of the knee. Biol Sex Differ. 2013;4:4.

Hame SL, Alexander RA. Knee osteoarthritis in women. Curr Rev Musculoskelet Med. 2013;6:182-7.

Thijssen E, Van Caam A, van der Kraan PM. Obesity and osteoarthritis, more than just wear and tear: Pivotal roles for inflamed adipose tissue and dyslipidaemia in obesity-induced osteoarthritis. Rheumatol (United Kingdom). 2014;54:588-600.

Sathiyanarayanan S, Shankar S, Padmini SK. Usefulness of WOMAC index as a screening tool for knee osteoarthritis among patients attending a rural health care center in Tamil Nadu. Int J Community Med Public Health. 2017;4:4290-5.






Original Research Articles