Study Protocol: Efficacy of Jintiange Capsule in Lumbar Disc Herniation: A Single-Center, Randomized Controlled Trial

Lumbar disc herniation (LDH) is a leading cause of chronic low back pain (LBP), severely impairing patients' quality of life and imposing a substantial global socioeconomic burden. Conservative treatment remains the first-line clinical option, but the commonly prescribed drug celecoxib carries a risk of gastrointestinal bleeding or perforation. Traditional Chinese medicine preparations have been proposed as alternatives, although current evidence is insufficient. Jintiange (JTG) capsule, developed as a substitute for tiger bone, exerts its pharmacological effects by inhibiting osteoclastogenesis and regulating the NF-κB pathway. Previous studies have identified a close association between the p38MAPK/NF-κB pathway and pain induced by LDH. However, the efficacy of JTG in treating LDH remains unclear. High-quality research is thus urgently needed to provide evidence-based support for its clinical application.

This randomized, single-center clinical trial will enroll 68 participants, centrally allocated 1:1 to receive either JTG capsules plus comprehensive Western medicine (celecoxib + eperisone) or Western medicine alone. All participants will complete an 8-week treatment phase (celecoxib for 2 weeks + eperisone for 8 weeks; with JTG capsules added for 8 weeks in the experimental group), with a follow-up at Week 12 (4 weeks after treatment completion). The primary outcome is the change in the Japanese Orthopaedic Association (JOA) score for LBP, a validated instrument for evaluating treatment efficacy in LDH. Secondary outcomes include the Patient Global Impression of Change (PGIC), Visual Analog Scale (VAS) score, SF-12 quality-of-life score, and elastic modulus of the lumbar muscles. Safety monitoring and adverse-event recording will occur throughout the study. The primary endpoint will be analyzed using the analysis of covariance. Longitudinal VAS scores at Weeks 2, 8, and 12 will be analyzed using a mixed model for repeated measures. PGIC will be analyzed as an ordinal categorical outcome, while other secondary outcomes will be analyzed using appropriate parametric or nonparametric methods. All analyses will be performed using SPSS 28.0, with no interim analysis planned.

This trial will evaluate the clinical efficacy of JTG capsules combined with Western medicine for LBP and will explore its safety profile as a secondary/exploratory endpoint. Given the open-label combination design, safety findings will be interpreted with caution, and causality attribution to JTG alone will be limited. The findings are expected to provide an evidence-based treatment option, supporting the potential role of Chinese patent medicine in LBP management.

Chinese Registry of Clinical Trials: ChiCTR2300069735.