Evidence map›Paper›PMID 36562843›Full record

ArticleJournal of experimental orthopaedics2022

Efficacy and safety of native type II collagen in modulating knee osteoarthritis symptoms: a randomised, double-blind, placebo-controlled trial.

Cheng Luo, Weike Su, Ying Song, Shalini Srivastava

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of experimental orthopaedics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04470336 (A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04470336 nacompletednot on this map

A Double-blind, Placebo-controlled, Randomized, Parallel Study to Assess the Efficacy of Collagen Supplement in Osteoarthritis

TypeinterventionalSponsorVedic Lifesciences Pvt. Ltd.Ran2020 to 2021Enrolled102ConditionsKnee OsteoarthritisArmsCollagen Supplement, Glucosamine chondroitin, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Cheng LuoResearch and Development, Jiaxing Hengjie Biopharmaceutical Co. Ltd, No.20 Tongyi Road, Xinfeng Industrial Park, Jiaxing, 314005, Zhejiang, China.
Weike SuDepartment of Pharmacology, Zhejiang University of Technology, Hangzhou, 310023, Zhejiang, China.
Ying SongDepartment of Pharmacology, Zhejiang University of Technology, Hangzhou, 310023, Zhejiang, China.
Shalini SrivastavaClinical Development, Vedic Lifesciences Pvt. Ltd, 118, Morya House, Off New Link Road, Andheri (West), Mumbai, 400053, Maharashtra, India. shalini.s@vediclifesciences.com.ORCID http://orcid.org/0000-0001-8497-5929
Zhejiang University of Science and Technology · CNJiaxing University · CNVedic Lifesciences (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeKnee 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.

methodsWe 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.

resultsCompared 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.

conclusionTII 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 registrationClinicalTrials.gov Identifier: NCT04470336 ; First submitted date: July 08, 2020; First posted date: July 14, 2020.

Indexed as

Glucosamine hydrochloride, chondroitin sulfateKnee osteoarthritisNative type II collagenUndenatured collagen type IIWOMAC

Identifiers

PMID36562843
PMCPMC9780623
OpenAlexW4312179231

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.