Table 7.
Serum and whole blood clinical markers of safety.
| Between-Group Comparison | |||||||
|---|---|---|---|---|---|---|---|
| Variables | N | Baseline (Week 0) |
Post (Week 12) |
Within p-Value |
Mean Difference | 95% CI | p-Value |
| White blood cell count (cells/μL) | |||||||
| S500 PLA |
19 19 |
5.88 ± 1.36 5.54 ± 1.50 |
6.48 ± 1.40 5.68 ± 1.83 |
0.14 0.68 |
0.46 ± 0.51 | (−0.56, 1.49) | 0.37 |
| Red blood cell count (cells/μL) | |||||||
| S500 PLA |
19 19 |
5.08 ± 0.29 5.07 ± 0.36 |
5.08 ± 0.24 5.21 ± 0.42 |
0.97 0.01 † |
−0.15 ± 0.07 | (−0.29, −0.01) | 0.04 ‡ |
| Hemoglobin (g/dL) | |||||||
| S500 PLA |
19 19 |
15.5 ± 0.24 15.4 ± 0.90 |
15.2 ± 0.53 15.8 ± 0.94 |
0.03 † 0.02 † |
−0.64 ± 0.19 | (−1.03, −0.26) | 0.002 ‡ |
| Hematocrit (%) | |||||||
| S500 PLA |
19 19 |
43.5 ± 2.42 43.4 ± 2.33 |
43.5 ± 1.75 44.7 ± 2.87 |
0.85 0.01 † |
−1.37 ± 0.62 | (−2.63, −0.11) | 0.03 ‡ |
| Glucose (g/dL) | |||||||
| S500 PLA |
19 19 |
87.9 ± 8.4 89.5 ± 6.3 |
90.8 ± 4.7 90.4 ± 5.7 |
0.18 0.63 |
2.11 ± 2.69 | (−3.35, 7.56) | 0.44 |
| Blood Urea Nitrogen (mg/dL) | |||||||
| S500 PLA |
19 19 |
14.5 ± 3.55 15.1 ± 3.85 |
14.3 ± 3.0 14.7 ± 3.1 |
0.72 0.60 |
0.16 ± 0.91 | (−1.69, 2.00) | 0.86 |
| Creatinine (mg/dL) | |||||||
| S500 PLA |
19 19 |
1.01 ± 0.15 0.98 ± 0.13 |
1.08 ± 0.14 1.02 ± 0.13 |
0.03 † 0.11 |
0.02 ± 0.04 | (−0.05, 0.10) | 0.56 |
| Blood Urea Nitrogen/Creatinine Ratio | |||||||
| S500 PLA |
19 19 |
14.5 ± 3.2 15.8 ± 5.3 |
13.5 ± 2.9 14.8 ± 4.1 |
0.19 0.24 |
−0.05 ± 1.13 | (−2.34, 2.23) | 0.96 |
| Sodium (mEq/L) | |||||||
| S500 PLA |
19 19 |
141.6 ± 1.39 141.2 ± 1.64 |
141.1 ± 1.24 140.5 ± 1.78 |
0.29 0.13 |
0.21 ± 0.61 | (−1.02, 1.45) | 0.73 |
| Potassium (mEq/L) | |||||||
| S500 PLA |
19 19 |
4.44 ± 0.32 4.40 ± 0.22 |
4.33 ± 0.26 4.34 ± 0.21 |
0.10 0.21 |
−0.04 ± 0.08 | (−0.20, 0.12) | 0.59 |
| Chloride (mEq/L) | |||||||
| S500 PLA |
19 19 |
101.1 ± 1.99 100.9 ± 1.70 |
101.2 ± 1.99 100.6 ± 1.77 |
0.77 0.48 |
0.47 ± 0.70 | (−0.94, 1.89) | 0.50 |
| Carbon Dioxide (mEq/L) | |||||||
| S500 PLA |
19 19 |
24.7 ± 1.77 24.1 ± 1.78 |
24.3 ± 1.73 23.2 ± 2.41 |
0.34 0.18 |
0.47 ± 0.77 | (−1.09, 2.03) | 0.54 |
| Protein (g/dL) | |||||||
| S500 PLA |
19 19 |
7.36 ± 0.43 7.15 ± 0.28 |
7.20 ± 0.40 7.31 ± 0.33 |
0.16 0.12 |
−0.32 ± 0.14 | (−0.61, −0.02) | 0.04 |
| Albumin (g/dL) | |||||||
| S500 PLA |
19 19 |
4.80 ± 0.30 4.74 ± 0.19 |
4.67 ± 0.25 4.78 ± 0.20 |
0.04 † 0.53 |
−0.16 ± 0.08 | (−0.33, 0.00) | 0.05 |
| Globulin (g/dL) | |||||||
| S500 PLA |
19 19 |
2.56 ± 0.26 2.41 ± 0.28 |
2.53 ± 0.25 2.53 ± 0.34 |
0.72 0.23 |
−0.15 ± 0.13 | (−0.41, 0.11) | 0.24 |
| Albumin/Globulin Ratio | |||||||
| S500 PLA |
19 19 |
1.89 ± 0.22 2.00 ± 0.29 |
1.86 ± 0.21 1.93 ± 0.28 |
0.60 0.42 |
0.03 ± 0.11 | (−0.19, 0.25) | 0.77 |
| Bilirubin (mg/dL) | |||||||
| S500 PLA |
19 19 |
0.58 ± 0.32 0.71 ± 0.45 |
0.59 ± 0.28 0.74 ± 0.41 |
0.88 0.52 |
−0.03 ± 0.09 | (−0.21, 0.16) | 0.77 |
| Alkaline Phosphatase (U/L) | |||||||
| S500 PLA |
19 19 |
66.4 ± 14.4 73.9 ± 21.4 |
64.2 ± 11.5 74.3 ± 19.9 |
0.46 0.85 |
−2.58 ± 3.5 | (−9.68, 4.52) | 0.47 |
| Aspartate Aminotransferase (U/L) | |||||||
| S500 PLA |
19 19 |
24.3 ± 9.2 24.8 ± 7.8 |
22.8 ± 8.2 25.9 ± 8.1 |
0.24 0.61 |
−2.68 ± 2.56 | (−7.88, 2.51) | 0.30 |
| Alanine Aminotransferase (U/L) | |||||||
| S500 PLA |
19 19 |
20.6 ± 9.1 24.8 ± 7.8 |
22.8 ± 8.2 25.9 ± 8.1 |
0.88 0.24 |
−2.37 ± 2.40 | (−7.23, 2.50) | 0.33 |
| Total Cholesterol (mg/dL) | |||||||
| S500 PLA |
19 19 |
157.2 ± 31.9 181.3 ± 44.9 |
155.2 ± 28.6 184.3 ± 43.5 |
0.51 0.49 |
−5.0 ± 5.2 | (−15.5, 5.5) | 0.34 |
| Triglycerides (mg/dL) | |||||||
| S500 PLA |
19 19 |
72.7 ± 21.7 130.4 ± 114.8 |
80.5 ± 35.6 116.5 ± 66. |
0.36 0.38 |
21.7 ± 17.5 | (−13.8, 57.2) | 0.22 |
| High Density Lipoprotein Cholesterol (mg/dL) | |||||||
| S500 PLA |
19 19 |
53.3 ± 10.8 47.7 ± 7.2 |
51.4 ± 11.5 47.9 ± 7.7 |
0.23 0.86 |
−2.16 ± 1.95 | (−6.11, 1.80) | 0.28 |
| Very Low Density Lipoprotein Cholesterol (mg/dL) | |||||||
| S500 PLA |
19 19 |
14.4 ± 4.5 21.8 ± 14.2 |
16.1 ± 7.0 23.3 ± 13.4 |
0.33 0.94 |
1.74 ± 2.23 | (−2.78, 6.27) | 0.44 |
| Low Density Lipoprotein Cholesterol (mg/dL) | |||||||
| S500 PLA |
19 19 |
89.4 ± 30.5 107.1 ± 34.3 |
87.8 ± 25.3 113.2 ± 36.6 |
0.59 0.33 |
−6.19 ± 5.34 | (−17.0, 4.6) | 0.25 |
S500 = 500 mg daily dose of ashwagandha; PLA = placebo. 95% CI = 95% confidence interval of the difference between S500 and PLA. Within p-value = Factorial ANOVA with repeated measures on time. Between-group p-values were calculated using independent t-tests using the delta value (week 12–week 0). † indicates significant within-group differences, ‡ indicates significant between group differences.