Traditional Vietnamese herbal medicine TD0015 in Knee Osteoarthritis: A Phase-II randomized controlled trial
Why this work is in the frame
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Bibliographic record
Abstract
Background: Knee osteoarthritis (KOA) is a leading cause of disability among older adults worldwide. Traditional medicine offers a promising treatment for KOA with fewer side effects compared to current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids. This study aimed to evaluate the safety and efficacy of TD0015, a herbal formulation based on the Duhuo Jisheng decoction, in treating KOA. Methods: This randomized, double-blind, placebo-controlled trial enrolled 108 patients with KOA. Participants were randomly assigned in a 1:1:1 ratio to receive TD0015 5 g, TD0015 7.5 g, or placebo daily for 60 days. Efficacy endpoints included changes in Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), Visual Analogue Scale (VAS), Lequesne index, heel-buttock distance, and knee flexion and extension range of motion. Safety was assessed by adverse events (AEs). Results: The mean age was around 60 years, and >80 % were females. Both TD0015 treatment groups significantly improved the WOMAC, VAS, Lequesne score, heel-buttock distance, and knee flexion and extension during the treatment period. At the 90-day follow-up, the mean percentage improvement in WOMAC scores was 74.5 % ± 13.4 %, 83.9 % ± 14.8 %, and 7.4 % ± 31.5 % in the TD0015 5 g, TD0015 7.5 g, and placebo groups, respectively, which corresponds to a 67.1 % (95 % CI: 56.3-77.9) and 76.5 % (95 % CI: 65.6-87.4) improvement in the TD0015 5 g and TD0015 7.5 g groups, compared to placebo. No AEs were reported in any group. Conclusions: The Vietnamese herbal medicine TD0015 is safe, efficacious, and well-tolerated in treating KOA. Further studies are required to confirm the long-term efficacy and safety of TD0015. Trial registration: ClinicalTrials.gov, NCT06657495.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.014 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.003 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 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 it