Lumbar disc herniation with radiculopathy: Study protocol of a randomized controlled clinical trial evaluating the efficacy of Ayurveda treatment protocol. (Preprint)

BACKGROUND The single leading cause of disability worldwide is low back pain. The incidence of herniated disc is about 5-20 cases per 1000 adults per year and is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, disease Grudhrasi simulates radiculopathy. In modern medicine, the first line of treatment includes conservative management including patient education, manual therapy, and non-steroidal anti-inflammatory drugs (NSAIDs). Ayurveda treatment are used to manage lumbar radiculopathy. OBJECTIVE This clinical study aims to compare the safety and efficacy of Ayurveda treatment protocol with standard care in lumbar disc herniation with radiculopathy METHODS This is an open-labelled, randomized, controlled parallel group clinical trial with sample size of 80 participants to be randomly allocated into two groups. The intervention group receive Ayurveda treatment protocol and the control group will be treated with standard modern care including physiotherapy for a period of 60 days. The changes in Numeric pain assessment scale - VAS score and ODI (Oswestry disability index Version 2.0) score will be taken as the primary outcome measures and will be recorded at baseline (1st day), 8th day (after completing IP treatment), 30th day, and 60th day. The secondary outcome quality of life will be recorded at baseline (1st day), 8th day (after completing IP treatment), 30th day, and 60th day, occurrence of adverse events and need of rescue analgesic medications will be taken as other secondary outcome measures and will be recorded at 8th day (after completing IP treatment), 30th day, and 60th day. RESULTS The project was funded in March 2023, and the study period is 36 months. The participant enrollment was started on November 2023. As of May 2025, 58 participants completed the study. The data analysis will be completed by March 2026, and the results are expected to be published by May 2026. CONCLUSIONS Lumbar disc herniation with radiculopathy affects the quality of life in patients. Ayurveda offers sustainable relief for lumbar disc herniation with radiculopathy. This study will provide scientific evidence on the safety and efficacy of Ayurveda treatment protocol in lumbar disc herniation with radiculopathy CLINICALTRIAL Clinical Trial Registry of India (CTRI) (CTRI/2023/05/052859).