Table 2.
Summary of efficacy endpoint results: mean (SE) values and mean change (SE) from baseline values of Zenroot™ versus placebo
| Sr. no | Measurement parameter | Mean (SE) values | Mean change (SE) from baseline values | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Day 14 | Day 28 | Day 56 | Day 84 | Day 14 | Day 28 | Day 56 | Day 84 | |||||||||||
| ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ZEN | Placebo | ||
| 1 | Perceived Stress Scale (PSS) |
22.10 (0.30) |
22.20 (0.30) |
20.30 (0.30) |
20.80 (0.30) |
18.10 (0.30) |
20.60 (0.40) |
16.20 (0.30) |
21.30 (0.40) |
14.70 (0.30) |
22.90 (0.40) |
− 1.80 (0.30) |
− 1.30 (0.30) |
− 4.00 (0.30) |
− 1.50 (0.40) |
− 5.90 (0.30) |
− 0.80 (0.40) |
− 7.40 (0.30) |
0.80 (0.40) |
| p value | 0.9206 | 0.2886 | < .0001* | < .0001* | < .0001* | 0.2302 | < .0001* | < .0001* | < .0001* | ||||||||||
| 2 | Mindfield eSense Skin Response Assessment (SCR/min) |
9.28 (0.42) |
8.25 (0.38) |
7.33 (0.44) |
8.11 (0.44) |
6.73 (0.43) |
7.63 (0.41) |
6.21 (0.41) |
6.61 (0.42) |
5.30 (0.36) |
5.95 (0.48) |
− 1.88 (0.60) |
− 0.14 (0.52) |
− 2.58 (0.53) |
− 0.66 (0.61) |
− 3.01 (0.54) |
− 1.73 (0.54) |
− 4.02 (0.55) |
− 2.30 (0.61) |
| p value | 0.0708# | 0.2123 | 0.1385 | 0.4996 | 0.2785 | 0.0347* | 0.0209* | 0.0788# | 0.0336* | ||||||||||
| 3 | Mindfield eSense PULSE—Heart Rate Variability Assessment (RMSSD) |
36.07 (3.08) |
48.74 (3.31) |
45.23 (4.27) |
37.57 (2.81) |
37.57 (3.46) |
39.16 (3.40) |
32.80 (3.48) |
34.40 (3.31) |
32.81 (3.86) |
37.94 (3.79) |
9.22 (21.82) |
− 11.17 (3.49) |
1.50 (4.10) |
− 9.58 (4.66) |
− 3.27 (3.93) |
− 14.01 (4.49) |
− 3.26 (4.08) |
− 10.80 (5.05) |
| p value | 0.0064* | 0.1342 | 0.7410 | 0.7410 | 0.3456 | < .0001* | 0.0783# | 0.0756# | 0.2504 | ||||||||||
| 4 | Mindfield eSense PULSE—Heart Rate Variability Assessment (SDNN) |
53.47 (3.12) |
67.35 (3.59) |
62.12 (4.36) |
56.10 (2.92) |
57.65 (3.92) |
58.14 (3.59) |
49.27 (3.65) |
51.50 (3.43) |
50.16 (4.29) |
55.20 (3.85) |
8.29 (3.62) |
− 11.25 (3.30) |
4.18 (3.83) |
− 9.22 (4.68) |
− 4.20 (3.55) |
− 15.75 (4.28) |
− 3.31 (4.01) |
− 12.16 (4.87) |
| p value | 0.0046* | 0.2505 | 0.9206 | 0.6559 | 0.3828 | 0.0001* | 0.0298* | 0.0409* | 0.1653 | ||||||||||
| 5 | Beck Anxiety Inventory (BAI) Score |
18.90 (0.80) |
18.20 (0.80) |
18.20 (0.80) |
18.50 (0.90) |
15.00 (0.60) |
18.40 (0.70) |
12.60 (0.60) |
19.70 (0.80) |
10.60 (0.60) |
20.60 (0.60) |
− 0.70 (0.70) |
0.30 (0.70) |
− 3.90 (0.80) |
0.20 (0.70) |
− 6.20 (0.80) |
1.50 (0.60) |
− 8.30 (0.70) |
2.30 (0.60) |
| p value | 0.5556 | 0.7649 | 0.0008* | < .0001* | < .0001* | 0.3106 | 0.0002* | < .0001* | < .0001* | ||||||||||
| 6 | Profile of Mood States (POMS) Score |
77.70 (5.60) |
76.70 (5.80) |
71.20 (4.50) |
73.10 (5.00) |
55.30 (3.10) |
62.80 (3.80) |
37.00 (3.00) |
81.50 (5.30) |
23.70 (3.60) |
92.80 (3.70) |
− 6.50 (3.00) |
− 3.60 (3.70) |
− 22.40 (3.90) |
− 14.00 (4.40) |
− 40.60 (4.20) |
4.80 (3.40) |
− 54.00 (4.60) |
16.10 (3.90) |
| p value | 0.9206 | 0.7780 | 0.1281 | < .0001* | < .0001* | 0.5501 | 0.1568 | < .0001* | < .0001* | ||||||||||
| 7 | Pittsburgh Sleep Quality Index (PSQI) Global Score |
7.10 (0.20) |
6.90 (0.20) |
– | – |
5.70 (0.20) |
6.30 (0.20) |
4.60 (0.20) |
6.20 (0.20) |
4.10 (0.20) |
7.00 (0.30) |
– | – |
− 1.40 (0.20) |
− 0.60 (0.10) |
− 2.60 (0.20) |
− 0.70 (0.30) |
− 3.00 (0.20) |
0.10 (0.30) |
| p value | 0.4563 | - | 0.0279* | < .0001* | < .0001* | – | 0.0006* | < .0001* | < .0001* | ||||||||||
| 8 | Serum Cortisol level (μg/dL) |
8.59 (0.46) |
8.33 (0.51) |
8.25 (0.46) |
7.91 (0.36) |
– | – |
7.75 (0.48) |
8.01 (0.55) |
7.22 (0.41) |
6.77 (0.41) |
-0.35 (0.41) |
-0.23 (0.43) |
– | – |
− 1.05 (0.46) |
− 0.43 (0.56) |
− 1.44 (0.52) |
− 1.55 (0.46) |
| p value | 0.6995 | 0.5671 | – | 0.7299 | 0.4407 | 0.8420 | – | 0.3921 | 0.8629 | ||||||||||
| 9 | Salivary alpha-amylase level (U/L) |
2291.70 (462.00) |
2037.60 (224.70) |
– | – | – | – |
2239.30 (349.50) |
3492.80 (394.80) |
1899.10 (351.60) |
2414.50 (416.60) |
– | – | – | – |
− 52.40 (531.70) |
1406.00 (401.40) |
− 392.70 (561.00) |
376.90 (489.00) |
| p value | 0.6184 | – | – | 0.0197* | 0.3481 | – | – | 0.0314* | 0.3016 | ||||||||||
*p < 0.05 Significance over placebo
#p > 0.05 but p < 0.1 Trend over placebo