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

Abstract

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.

Keywords

Ruyi Zhenbao tablet / Tibetan medicine / Lumbar disc herniation / Randomized controlled trial / Efficacy / Protocol

Funding

The work was funded by Innovative Research on Evidence-Based Evaluation Methods for Clinical Efficacy of Traditional Chinese Medicine (90020172120103).

CRediT authorship contribution statement

Zhiqiang Li: Writing ‒ original draft, methodology, visualization, software, resources, and writing ‒ review & editing. Xinhu Guo: Conceptualization, and investigation, Wei Zhang: Methodology, data curation, and writing – review & editing. Bin Meng: Data curation, and writing – review & editing. Zhixiu Shen: Writing – review & editing, resources, and software. Dingkun Lin: Data curation, and writing – review & editing. Xiaolan Ji: Data curation, and writing – review & editing. Yanxue Qiao: Writing – review & editing. Kailie Liu: Data curation, and writing – review & editing. Min Zhao: Data curation, and writing – review & editing. Long Zhao: Data curation, and writing – review & editing. Guangjie Yang: Data curation, and writing – review & editing. Zhaohui Hu: Data curation, and writing – review & editing. Xuexiao Ma: Data curation, and writing – review & editing. Chen Shen: Methodology, writing – review & editing, and resources. Zhaolan Liu: Methodology, writing – review & editing, software, and resources. Weishi Li: Conceptualization, investigation, supervision, and project administration, Jianping Liu: Conceptualization, investigation, supervision, and project administration.

Declaration of competing interest

The authors declare that they have no conflicts of interest. Prof. Jianping Liu is an editorial board member of Journal of Traditional Chinese Medical Sciences. He was excluded from the review process of this paper.

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