Zusammenfassung

Shalini Srivastava,1 Robert N Girandola2 1Department of Clinical Development, Enovate Biolife, Wilmington, DE, 19801, USA; 2Department of Human Biology, University of South California, Los Angeles, CA, USACorrespondence: Shalini Srivastava, Enovate Biolife, 913 N Market Street, Suite 200, Wilmington, DE, 19801, USA, Tel +91-9619477885, Email shalini@enovatebiolife.comPurpose: A randomized, double-blind, placebo-controlled cross-over study was conducted to investigate the efficacy and safety of E-PR-01, a proprietary formula containing Vitex negundo and Zingiber officinale, on knee joint discomfort due to pain.Patients and Methods: Forty adults aged 20– 60 years with self-reported pain score of ≤ 30 mm at rest and ≥ 60 mm post-exertion on a 100-mm visual analog scale (VAS) were randomized in a 1:1 ratio to receive either the E-PR-01 (200 mg twice daily) or placebo for 5 days. The primary outcome was time to achieve meaningful pain relief (MPR) (≥ 40% reduction in post-exertion pain VAS score from baseline) post-single dose of intervention on day 1 compared to placebo. The secondary outcomes were post-exertion pain intensity difference (PID) at 2-, 3- and 4-hours and time-weighted sum of pain intensity difference (SPID) over 4 hours post single dose on day 1; post-exertion VAS score at 4 hours’ post-intervention on day 5; percentage of responders on day 1; and physical efficiency as assessed by the total duration of exercise sessions completed after single dose of IP compared to placebo.Results: The average time to achieve MPR was 3.38 hours, 32.50% of participants achieved it in the E-PR-01 group post single-dose administration on day 1 as opposed to the placebo where no participant achieved MPR. There were significant intergroup differences in PID (− 23.58 vs 2.45 mm) and SPID (− 67.48 vs − 0.08 mm) at 4 hours of E-PR-01 and placebo administration on day 1. 95% of participants in the IP group experienced some degree of pain relief within 2 hours compared to 37.5% in the placebo group.Conclusion: A single dose of ...