Affiliations: [a] Department of Clinical Development, Enovate Biolife, Wilmington, DE, USA | [b] Ayush Nursing Home, Kandivali West, Mumbai, India | [c] Department of Human Biology, University of South California, Los Angeles, CA, USA
Correspondence:
[*]
Corresponding author: Shalini Srivastava, Enovate Biolife, 913 N Market Street, Suite 200, Wilmington, DE 19801, USA. Tel.: +1 91 9619477885; E-mail: shalini@enovatebiolife.com.
Abstract: BACKGROUND: Low back pain (LBP) has emerged as a major public health concern leading to significant work productivity loss and deterioration in the quality of life. OBJECTIVE: A randomized, double-blind, placebo-controlled parallel-group clinical trial was conducted to investigate the effect of E-PR-01, a proprietary blend of Vitex negundo leaves and zingiber officinale rhizome, in individuals with LBP. METHODS: Seventy-two individuals aged 18 to 60 years with LBP were randomized in a 1:1 ratio in either the E-PR-01 or placebo group. The participants were instructed to take 2 capsules/day of the study products in two divided doses for 30 days. The study outcomes were changes in functional activity, bending flexibility, pain intensity, work productivity, and sleep quality. The sustained effect of the study products was also evaluated on the pain and physical functioning for 7 days after stopping the product intake. The product’s safety was evaluated by adverse events reporting throughout the study. RESULTS: Compared to the placebo, the E-PR-01 demonstrated a statistically significant reduction in functional disability (mean RMQ score: -5.47 vs. -2.48), pain intensity (mean VAS score: -31.29 vs. -14.55) and improved bending flexibility (mean distance: -5.60 vs. -2.38 cm). In addition, a significant improvement in work productivity as well as sleep quality was also observed. In the E-PR-01 group, a statistically significant sustained effect was observed compared to the placebo for the pain intensity (p< 0.0005) and the functional activity (p< 0.0001) scores. No significant adverse event was reported in the study. CONCLUSION: E-PR-01 significantly improved low back pain and bending flexibility in adults without adverse effects. Moreover, the effect of E-PR-01 lasted 7 days after stopping the intervention.
Keywords: Low back pain, Vitex negundo, Zingiber officinale, physical function, work productivity, sleep quality
