A Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety and Efficacy of a Herbal Formulation on Knee Joint Function in Adults with Knee Osteoarthritis
Bibliographic record
Abstract
Background: Current treatments for osteoarthritis (OA) pain and stiffness have limitations, including adverse effects. Therefore, effective and safe complementary or alternative therapies are needed. Dietary supplement GJ 191, comprising Epimedium, Dioscorea, and Salvia miltiorrhiza extracts, may address this need. Methods: This randomized, double-blind, placebo-controlled study investigated GJ 191 supplementation on knee OA symptoms. Seventy-two adults (40–75 years) with mild to moderate knee OA and mild to moderate knee pain were enrolled. The Knee Injury and Osteoarthritis Outcome Score (KOOS), Pain Visual Analog Scale (VAS), Quality of Life questionnaire, knee joint range of motion, serum C-reactive protein, and rescue medication use were assessed. The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores were computed using KOOS scores. Results: Decreases in WOMAC pain scores were reported by both GJ 191 and placebo groups after 6 (−1.78 ± 2.71 and −1.34 ± 1.93, respectively; p < 0.01) and 12 (−2.31 ± 2.83 and −1.59 ± 2.69, respectively; p < 0.01) weeks, with no significant difference between groups. There were decreases in WOMAC stiffness scores for participants supplemented with GJ 191 by 0.53 ± 1.22 and 0.72 ± 1.46 ( p ≤0.02) after 6 and 12 weeks, respectively, with respective decreases of 0.81 ± 1.51 and 0.75 ± 1.85 ( p ≤0.03) for those on placebo. Significant improvements in current pain, as assessed by the Pain VAS, and bodily pain were reported by the GJ 191 group after 6 and 12 weeks, while the placebo group only reported significant improvements in these measures after 12 weeks. GJ 191 supplementation was safe and well tolerated. Conclusion: There was no significant difference in pain and stiffness scores between GJ 191 and placebo over the 12 weeks. While both groups reported improvements in WOMAC pain from baseline, improvements in current and bodily pain were experienced sooner with GJ 191 than placebo and were sustained over the study period. GJ 191 supplementation was safe and well tolerated. (CTR#: NCT04395547).
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".