Effect of E-PR-01 on non-specific low back pain in the adult population: A randomized, double-blind, placebo-controlled, parallel-group trial.

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.

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

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.

Effect of E-OJ-01 on Left Ventricular Ejection Fraction and Myocardial Oxygen Consumption: A Randomized, Double-Blind, Placebo-Controlled Study.

Purpose: E-OJ-01 (OxyjunTM), a proprietary, standardized aqueous extract of Terminalia arjuna (TA) bark, has previously shown promising cardiovascular health benefits in healthy young athletic adults and is now being tested to determine its ability to support left ventricular ejection fraction and associated parameters in a diverse population. Participants and Methods: Healthy adults aged 30-70 years (n=72) were included in the study to investigate the effect of 400 mg/day of E-OJ-01 when administered for 8 weeks on myocardial pumping capacity, primarily left ventricular ejection fraction (LVEF). The secondary endpoints were improvement in diastolic filling (E/A) ratio, rate pressure product (RPP), and fatigue severity scale (FSS) score. The effect of the intervention on blood lipids and gamma-glutamyltransferase (GGT) levels was also explored. The safety of the intervention was evaluated by monitoring adverse events, vitals (heart rate (HR), blood pressure (BP), and body temperature (BT)), and liver (serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT)) and kidney function (serum creatinine). Results: E-OJ-01 increased the LVEF by 6.28% (percentage change) from the baseline compared with 0.24% (percentage change) in the placebo group (p<0.05). It reduced fatigue (22.52%), RPP (1.54%), and GGT levels (5.90%) from the baseline. No adverse events related to the intervention were observed during the study. Conclusion: The study showed that E-OJ-01 could improve cardiac pumping capacity by significantly increasing LVEF and reducing fatigue in a diverse, healthy population.

Effect Of E-OA-07 On Improving Joint Health And Mobility In Individuals With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study.

AIM: The aim of the present study was to evaluate the effect of E-OA-07 on individuals having osteoarthritis of the knee. BACKGROUND: Lanconone® (E-OA-07) is a widely marketed dietary supplement which has been previously studied in different clinical settings for managing chronic joint pain. This was a confirmatory study planned at a lowered dose regimen with the purpose of improving compliance and reducing consumer cost. METHODS: Male and female participants aged between 40 and 65 years, with history of joint pain for at least 3 years, were recruited. Knee joint dysfunction of grade II/III was radiographically characterized as per Kellgren-Lawrence system of classification. Enrolled participants were randomized to receive E-OA-07 at a dose of 1000 mg/day or placebo over a period of 8 weeks. The primary efficacy parameter was assessment of change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Whereas, the secondary parameters explored in the study included WOMAC subscales of stiffness and physical function, EQ-5D-5L questionnaire, systemic inflammatory marker (hs-CRP) and self-assessment of treatment satisfaction. RESULTS: At the end of 8 weeks, joint pain severity as per WOMAC was found to be significantly reduced in the E-OA-07 group as compared to placebo (p<0.001). Similar improvement was observed in the subscales of stiffness and physical function which corresponds to significant improvement in the quality-of-life standards of E-OA-07 participants (p<0.001), reporting higher treatment satisfaction (p<0.001). CONCLUSION: E-OA-07 at a dose of 1000 mg/day was able to significantly reduce joint pain and thereby improve joint mobility in study participants. At the end of the study period, there was a clinically relevant change of 45.55%, 45.91% and 38.19% for pain, stiffness and physical function, respectively. Moving forward, studies could be planned for understanding the cartilage regenerative properties of E-OA-07.

Effect of E-OJ-01 on Cardiac Conditioning in Young Exercising Adults: A Randomized Controlled Trial.

BACKGROUND AND AIM: Cardiac health is a determinant of athletic performance. A body of data suggests that in healthy young adults, an increase in maximal cardiac output leads to an increase in endurance. Terminalia arjuna (TA) has been studied for multiple benefits in cardiovascular health although its effects as a cardioprotective ergogenic aid require further exploration. The current trial was planned to study the effect of the proprietary TA extract (E-OJ-01) on the markers of cardiac conditioning in healthy young adults. STUDY QUESTION: No study has assessed the effect of TA extract on cardiac conditioning by improvement of left ventricular ejection fraction (LVEF) in young exercising individuals. STUDY DESIGN, MEASURES AND OUTCOMES: A randomized, double-blind, placebo-controlled, parallel group study was conducted to determine the efficacy and safety of E-OJ-01 for use as an ergogenic supplements in young exercising adults. This trial was registered at ClinicalTrials.gov (NCT02207101) and reported according to Consolidated Standards of Reporting Trials (CONSORT) requirements. Thirty-two healthy males, aged 18-40 years performing regular endurance exercise, were randomly assigned to 400 mg of E-OJ-01 or placebo for 56 days. LVEF, right and left ventricular Myocardial Performance Index, and Borg Rated Perceived Exertion (RPE) were assessed at baseline, day 28, and day 56; creatine kinase-MB and troponin-T were assessed at baseline and at day 56. RESULTS: As compared with placebo, 56 days of E-OJ-01 supplementation significantly improved the LVEF (P = 0.0001) and decreased the right ventricular Myocardial Performance Index (P = 0.001). The fatigue level captured by Borg Scale after completion of exercise showed a greater decrease in the E-OJ-01 group as compared with placebo. Creatine kinase-MB and troponin-T did not change significantly. CONCLUSIONS: TA (E-OJ-01) significantly increased cardiovascular efficiency and improved the cardiac conditioning in young healthy adults.

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

BACKGROUND: To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). METHOD: The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. RESULT: Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. CONCLUSION: The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. TRIAL REGISTRATION: Clinical trials.gov NCT02417506 . 21 January 2015.