Clinical benefits of undenatured chicken collagen type II Unstergen® as a nutritional therapy in the management of osteoarthritis: a double-blind, placebo controlled clinical study

Authors

  • Sriraam V. T. Aurous HealthCare Research and Development India Pvt. Ltd., Kodambakkam, Chennai, Tamil Nadu, India
  • Shakthi Pillai Aurous HealthCare Research and Development India Pvt. Ltd., Kodambakkam, Chennai, Tamil Nadu, India
  • Raja Singla Titan Biotech Limited, Netaji Subhash Place, Delhi, New Delhi, India
  • Shivom Singla Titan Biotech Limited, Netaji Subhash Place, Delhi, New Delhi, India

DOI:

https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20250900

Keywords:

OA, Undenatured chicken collagen, Type II collagen, Collagen, Unstergen, WOMAC, Pain scale, Nutraceuticals, Joint pain, Joint health

Abstract

Background: Osteoarthritis (OA) is a degenerative joint disease affecting millions globally, often leading to pain and reduced mobility. Nutraceuticals like undenatured chicken collagen   are gaining attention for their potential in symptom relief. This proof-of-concept study evaluates the clinical efficacy of Unstergen® of Titan Biotech Limited in the management of OA.

Methods: This randomised, double-blind, placebo-controlled study studies 48 adults with OA. Subjects received 40 mg/day of Unstergen® (n=32) or placebo (n=16) once a day for 90 days. Outcomes were assessed using WOMAC score, pain scale, quality of life questionnaire (QoL) for all and global rating of change scale (GROC) using X ray of target joint for a cohort of 12 subjects.

Results: Unstergen group demonstrated statistically significant reduction of 20.39% in Western Ontario and McMaster universities osteoarthritis index (WOMAC) scores and 37.77% in pain numerical rating scale (Pain NRS) compared to 7.24% and 8.70% reduction in the placebo arm, respectively. The 90.32% subjects reported improvement in QoL compared to placebo (p<0.05). The 87.50% subjects were deemed to have marked improvement on their X ray while no subject in the placebo arm showed improvement after 90 days. No adverse event was attributed to Unstergen and was deemed clinically safe.

Conclusions: Unstergen® demonstrated significant improvement in pain, function and QoL; highlighting its role as a novel nutraceutical supplementation therapy for OA.

Metrics

Metrics Loading ...

References

Martel-Pelletier J, Barr AJ, Cicuttini FM, Philip GC, Cyrus C, Mary BG, et al. Osteoarthritis. Nat Rev Dis Primers. 2016;2:16072. DOI: https://doi.org/10.1038/nrdp.2016.72

Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res.2016;474(8):1886-93. DOI: https://doi.org/10.1007/s11999-016-4732-4

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):518-22. DOI: https://doi.org/10.4103/0019-5413.189608

Prabhoo R, Billa G. Undenatured collagen type II for the treatment of osteoarthritis: a review. Int J Res Orthop. 2018;4(5):684. DOI: https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20183386

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. 2015;15:14. DOI: https://doi.org/10.1186/s12937-016-0130-8

García-Coronado JM, Martínez-Olvera L, Elizondo-Omaña RE, et al. Effect of collagen supplementation on osteoarthritis symptoms: a meta-analysis of randomized placebo-controlled trials. Int Orthop. 2019;43(3):531-8. DOI: https://doi.org/10.1007/s00264-018-4211-5

Ma C, Yu M, Huang Z, Wang J, Zhao X, Kang C, et al. Oral administration of hydrolysates of cartilage extract in the prevention of osteoarthritis. J Funct Foods. 2021;78:104376. DOI: https://doi.org/10.1016/j.jff.2021.104376

Chen CC, Chang SS, Chang CH, Hu CC, Nakao Y, Yong SM, et al. Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions. Nutr J. 2023;22(1):837. DOI: https://doi.org/10.1186/s12937-023-00837-w

Luo C, Su W, Song Y, Srivastava S. Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled trial. J Exp Orthop. 2022;9(1):123. DOI: https://doi.org/10.1186/s40634-022-00559-8

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. DOI: https://doi.org/10.5152/eurasianjmed.2015.15030

Bellamy N, Buchanan WW. A preliminary evaluation of the dimensionality and clinical importance of pain and disability in osteoarthritis of the hip and knee. Clin Rheumatol. 1986;5(2):231-41. DOI: https://doi.org/10.1007/BF02032362

Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004;8(4):283-91. DOI: https://doi.org/10.1016/j.ejpain.2003.09.004

©EuroQol Research Foundation. Available at: https://euroqol.org/. Accessed on 15 January 2024.

Kamper SJ, Maher CG, Mackay G. Global rating of change scales: A review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. DOI: https://doi.org/10.1179/jmt.2009.17.3.163

Shiojima Y, Takahashi M, Takahashi R, Kazuo M, Hiroyoshi M, Debasis B, et al. Efficacy and safety of dietary undenatured type II collagen on joint and motor function in healthy volunteers: a randomized, double-blind, placebo-controlled, parallel-group study. J Am Nutr Assoc. 2023;42(3):224-41. DOI: https://doi.org/10.1080/07315724.2021.2024466

Mohammed A, He S. A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy of a Hydrolyzed Chicken Collagen Type II Supplement in Alleviating Joint Discomfort. Nutrients. 2021;13(7):2454. DOI: https://doi.org/10.3390/nu13072454

Downloads

Published

2025-03-27

How to Cite

V. T., S., Pillai, S., Singla, R., & Singla, S. (2025). Clinical benefits of undenatured chicken collagen type II Unstergen® as a nutritional therapy in the management of osteoarthritis: a double-blind, placebo controlled clinical study. International Journal of Research in Orthopaedics, 11(3), 505–512. https://doi.org/10.18203/issn.2455-4510.IntJResOrthop20250900

Issue

Section

Original Research Articles