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.