Efficacy and Safety of a Highly Bioavailable Curcumin Formulation in Modulating Outcomes of Mild Knee Osteoarthritis: Multi-Centric, Randomized, Double-Blind, Placebo-Controlled Study
Bibliographic record
Abstract
Background: Osteoarthritis (OA) is a degenerative disease of joints affecting aging population worldwide with significant unmet medical needs.Here we report efficacy and safety of a highly bioavailable curcumin formulation, Curcuwin Ultra+ (CU+) in subjects with mild knee OA.Methods: Forty-five subjects each for CU+ 250 mg, CU+ 500 mg, and placebo groups with mild knee OA were randomized in a multi-centric, double-blind, parallel, placebo-controlled study with a treatment period of 84 days.A range of primary and secondary endpoints were assessed at baseline, day 5, 28, 56 and 84.The trial was prospectively registered on Clinical Trials Registry -India (CTRI/2021/10/037187) dated 08/10/2021.Results: A significant improvement (p<0.05) was observed in total Western Ontario McMaster Universities Osteoarthritis Index score (WOMAC), VAS pain, walking performance, range of motion (ROM) for knee extension and muscle strength as early as 5 days in CU+ 500 mg group as compared to placebo.Further, both groups of CU+ demonstrated significant reductions (p<0.05) in total WOMAC, WOMAC-pain, WOMAC-stiffness, WOMAC-physical function, VAS pain, and significant increases (p<0.05) in walking performance, knee extension and flexion muscle strength on days 28, 56, and 84 as compared to placebo.Moreover, ROM knee flexion was significantly decreased (p<0.05) on days 28, 56, and 84 in CU+ 500 mg and day 84 in CU+ 250 mg.Serum biomarkers like IL-1β, hsCRP, CTX-II and MMP3 were significantly reduced (p<0.05) on day 84 in CU+ 500 mg group.The use of rescue medication was significantly reduced
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".