Effect of E-PR-01 on Activity-Induced Acute Knee Joint Discomfort in Healthy Individuals: A Randomized, Placebo-Controlled, Double-Blind, Cross-Over Study

Abstract

Purpose

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 E-PR-01 provided a statistically significant as well as clinically meaningful reduction in exercise-induced knee joint discomfort within 4 hours of administration.

Keywords:

• Vitex negundo
• Zingiber officinale
• joint discomfort
• pain VAS
• meaningful pain relief
• pain intensity difference

Data Sharing Statement

The study data is available from the corresponding author upon reasonable request.

Acknowledgments

The authors are grateful to all the participants and the research team at Vedic Lifesciences for contributing to the study.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Shalini Srivastava is affiliated with Enovate Biolife. The other author reports no conflicts of interest in this work.

Additional information

Funding

Enovate Biolife funded the study and provided the study products.