Efficacy and safety of Ruyi Zhenbao tablet in patients with lumbar disc herniation: A protocol for a multicenter, randomized, positive-controlled trial

Objective: To evaluate the efficacy and safety of Ruyi Zhenbao tablet (RYZBT), a traditional Tibetan medicinal formula, for the treatment of lumbar disc herniation (LDH), that is frequently associated with lower back pain (LBP), through rigorous randomized controlled trials (RCTs). Methods: This multicenter, randomized, positive-controlled trial study will include 400 participants diagnosed with LDH, and include an enrollment period, a 4-week treatment period, and a 4-week follow-up period. Participants will be randomly assigned at a 1:1 ratio for treatment with either RYZBT or diclofenac sodium sustained-release tablet (DSSRT) for 4 weeks. The time points of visits are set at baseline, during treatment (weeks 1, 2, and 4), and during follow-up (weeks 2 and 4 post-treatment). The relevant outcome will be recorded at each timepoint. The primary outcomes include the Visual Analog Scale (VAS) scores for LBP and leg pain, as well as the Japanese Orthopaedic Association scores for functional assessment. Secondary outcomes comprise the VAS scores for numbness, Oswestry Disability Index, rescue treatments, patient health education, and safety assessments. Discussion: This study has been designed to provide robust and reliable evidence of the efficacy and safety of RYZBT in alleviating LDH symptoms, with the goal of supporting evidence-based clinical applications. By using DSSRT as a positive control, the placebo effect will be effectively minimized, enabling a more accurate assessment of RYZBT efficacy.