Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial
Abstract Purpose Knee osteoarthritis (OA) is the most common form of clinical arthritis in middle‐aged and older individuals. Undenatured or native type II (TII) collagen derived from the chicken sternum has a good therapeutic effect on relieving severe pain of OA. Hence, the present study aimed to...
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| Language: | English |
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Wiley
2022-01-01
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| Series: | Journal of Experimental Orthopaedics |
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| Online Access: | https://doi.org/10.1186/s40634-022-00559-8 |
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| author | Cheng Luo Weike Su Ying Song Shalini Srivastava |
| author_facet | Cheng Luo Weike Su Ying Song Shalini Srivastava |
| author_sort | Cheng Luo |
| collection | DOAJ |
| description | Abstract Purpose Knee osteoarthritis (OA) is the most common form of clinical arthritis in middle‐aged and older individuals. Undenatured or native type II (TII) collagen derived from the chicken sternum has a good therapeutic effect on relieving severe pain of OA. Hence, the present study aimed to investigate the efficacy and safety of TII collagen (Native CT‐II®) in individuals with knee OA. Methods We conducted a 12‐week randomised, double‐blind, placebo‐controlled, parallel‐group study on 101 participants aged 40–65 years with knee OA. The participants were randomised to receive either TII collagen, glucosamine hydrochloride + chondroitin sulfate (G + C) or a placebo. The primary outcome was an improvement in the joint health of the participants assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) compared to G + C and placebo. Results Compared with the placebo group (n = 27), the TII collagen group (n = 29) and G + C group (n = 29) significantly improved the overall joint health measured by the change in WOMAC total score (week 12: TII collagen = ‐32.47 ± 19.51 and G + C = ‐33.74 ± 24.64 vs. placebo = ‐13.84 ± 17.61; p < 0.05) and relieved knee joint pain (week 12: TII collagen = ‐5.69 ± 3.66 and G + C = ‐6.03 ± 4.72 vs. placebo = ‐2.71 ± 3.95; p < 0.05). The statistically significant effect was observed as early as 4 weeks after the investigational product administration. Additionally, the TII collagen was more effective in improving the quality of life than the G + C. Conclusion TII collagen not only has a significantly better effect and high safety profile for OA but also improves the quality of life of patients. Level of Evidence Level 1 – Randomized Controlled Trial. Trial registration ClinicalTrials.gov Identifier: NCT04470336; First submitted date: July 08, 2020; First posted date: July 14, 2020. |
| format | Article |
| id | doaj-art-eb5861ded8c54a42813bc22b3adb657d |
| institution | DOAJ |
| issn | 2197-1153 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Experimental Orthopaedics |
| spelling | doaj-art-eb5861ded8c54a42813bc22b3adb657d2025-08-20T03:19:21ZengWileyJournal of Experimental Orthopaedics2197-11532022-01-0191n/an/a10.1186/s40634-022-00559-8Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trialCheng Luo0Weike Su1Ying Song2Shalini Srivastava3Research and DevelopmentJiaxing Hengjie Biopharmaceutical Co. LtdNo.20 Tongyi Road, Xinfeng Industrial Park314005JiaxingZhejiangChinaDepartment of PharmacologyZhejiang University of Technology310023HangzhouZhejiangChinaDepartment of PharmacologyZhejiang University of Technology310023HangzhouZhejiangChinaClinical DevelopmentVedic Lifesciences Pvt. Ltd118, Morya House, Off New Link Road, Andheri (West)400053MumbaiMaharashtraIndiaAbstract Purpose Knee osteoarthritis (OA) is the most common form of clinical arthritis in middle‐aged and older individuals. Undenatured or native type II (TII) collagen derived from the chicken sternum has a good therapeutic effect on relieving severe pain of OA. Hence, the present study aimed to investigate the efficacy and safety of TII collagen (Native CT‐II®) in individuals with knee OA. Methods We conducted a 12‐week randomised, double‐blind, placebo‐controlled, parallel‐group study on 101 participants aged 40–65 years with knee OA. The participants were randomised to receive either TII collagen, glucosamine hydrochloride + chondroitin sulfate (G + C) or a placebo. The primary outcome was an improvement in the joint health of the participants assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) compared to G + C and placebo. Results Compared with the placebo group (n = 27), the TII collagen group (n = 29) and G + C group (n = 29) significantly improved the overall joint health measured by the change in WOMAC total score (week 12: TII collagen = ‐32.47 ± 19.51 and G + C = ‐33.74 ± 24.64 vs. placebo = ‐13.84 ± 17.61; p < 0.05) and relieved knee joint pain (week 12: TII collagen = ‐5.69 ± 3.66 and G + C = ‐6.03 ± 4.72 vs. placebo = ‐2.71 ± 3.95; p < 0.05). The statistically significant effect was observed as early as 4 weeks after the investigational product administration. Additionally, the TII collagen was more effective in improving the quality of life than the G + C. Conclusion TII collagen not only has a significantly better effect and high safety profile for OA but also improves the quality of life of patients. Level of Evidence Level 1 – Randomized Controlled Trial. Trial registration ClinicalTrials.gov Identifier: NCT04470336; First submitted date: July 08, 2020; First posted date: July 14, 2020.https://doi.org/10.1186/s40634-022-00559-8Undenatured collagen type IINative type II collagenGlucosamine hydrochloride, chondroitin sulfateWOMACKnee osteoarthritis |
| spellingShingle | Cheng Luo Weike Su Ying Song Shalini Srivastava Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial Journal of Experimental Orthopaedics Undenatured collagen type II Native type II collagen Glucosamine hydrochloride, chondroitin sulfate WOMAC Knee osteoarthritis |
| title | Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial |
| title_full | Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial |
| title_fullStr | Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial |
| title_full_unstemmed | Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial |
| title_short | Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double‐blind, placebo‐controlled trial |
| title_sort | efficacy and safety of native type ii collagen in modulating knee osteoarthritis symptoms a randomised double blind placebo controlled trial |
| topic | Undenatured collagen type II Native type II collagen Glucosamine hydrochloride, chondroitin sulfate WOMAC Knee osteoarthritis |
| url | https://doi.org/10.1186/s40634-022-00559-8 |
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