Table 8.
Safety Evaluation – Analysis of Hematological Parameters
| Parameter | Visit | Group A (N=18) VISPO-Oral | Group B (N=19) Placebo-Oral | Group C (N=18) VISPO-Topical | Group A (N=18) Placebo-Topical | ||||
|---|---|---|---|---|---|---|---|---|---|
| Hb (g/dL) | Baseline | 13.89±1.94 | 0.579# | 13.55±2.12 | 0.722# | 13.18±1.39 | 0.820# | 13.46±1.64 | 0.660# |
| EOS | 13.96±2.10 | 13.60±1.96 | 13.15±1.30 | 13.55±2.06 | |||||
| Change | 0.07±0.50 | 0.05±0.63 | −0.03±0.61 | 0.09±0.89 | |||||
| WBC (cells/mm3) | Baseline | 7426.67±2074.32 | 0.820# | 7093.10±1857.26 | 0.811# | 7861.67±1689.33 | 0.142# | 6938.33±1308.80 | 0.837# |
| EOS | 7362.78±1992.54 | 7026.32±1992.96 | 7453.89±1658.60 | 6869.44±1020.93 | |||||
| Change | −63.89±1171.13 | −66.84±1199.46 | 407.78±1122.87 | −68.89±1395.90 | |||||
| Neutrophils (%) | Baseline | 58.18±7.74 | 0.213# | 58.35±9.18 | 0.960# | 59.34±6.37 | 0.858# | 56.21±7.03 | 0.269# |
| EOS | 56.22±8.55 | 58.26±6.89 | 59.04±9.16 | 59.08±9.32 | |||||
| Change | −1.96±6.43 | −0.09±7.75 | −0.30±6.98 | 2.87±10.67 | |||||
| Lymphocytes (%) | Baseline | 31.14±6.19 | 0.073# | 30.86±8.82 | 0.954# | 29.11±5.73 | 0.328# | 32.37±8.13 | 0.433# |
| EOS | 33.97±7.16 | 30.96±5.84 | 30.38±7.83 | 30.95±8.39 | |||||
| Change | 2.82±6.26 | 0.10±7.46 | 1.27±5.36 | −1.42±7.52 | |||||
| Eosinophils (%) | Baseline | 3.99±2.57 | 0.285# | 3.97±2.13 | 0.798# | 5.18±4.37 | 0.079# | 3.11±1.79 | 0.618# |
| EOS | 3.65±2.34 | 3.86±2.50 | 4.45±4.08 | 2.94±1.74 | |||||
| Change | −0.34±1.30 | −0.11±1.86 | 0.73±1.66 | −0.17±1.44 | |||||
| Monocytes (%) | Baseline | 6.19±1.35 | 0.099# | 6.11±1.93 | 0.682# | 5.92±1.60 | 0.436# | 6.01±1.50 | 0.110# |
| EOS | 5.78±1.43 | 6.28±1.64 | 5.59±1.63 | 6.70±1.59 | |||||
| Change | −0.41±1.00 | 0.17±1.82 | −0.33±1.77 | 0.69±1.75 | |||||
| Basophils (%) | Baseline | 0.50±0.27 | 0.176# | 0.72±0.27 | 0.092# | 0.44±0.20 | 0.054# | 0.52±0.24 | 0.004#** |
| EOS | 0.39±0.23 | 0.56±0.28 | 0.54±0.21 | 0.33±0.20 | |||||
| Change | −0.11±0.33 | −0.15±0.37 | 0.10±0.21 | −0.19±0.24 | |||||
| PCV (%) | Baseline | 43.17±5.70 | 0.166# | 42.65±5.69 | 0.423# | 41.21±3.29 | 0.413# | 42.36±4.41 | 0.249# |
| EOS | 42.54±5.77 | 42.25±5.11 | 40.91±3.90 | 41.62±5.49 | |||||
| Change | −0.62±1.82 | −0.41±2.15 | −0.30±1.52 | −0.73±2.61 | |||||
| MCV (fL) | Baseline | 84.93±9.06 | 0.371# | 83.85±8.81 | 0.565# | 79.05±9.00 | 0.215# | 83.04±7.43 | 0.332# |
| EOS | 85.37±9.73 | 83.53±9.29 | 79.48±8.72 | 133.80±215.00 | |||||
| Change | 0.21±0.98 | −0.15±1.13 | 0.32±1.06 | 49.91±211.86 | |||||
| MCH (pg) | Baseline | 27.43±3.36 | 0.005#** | 26.61±3.69 | 0.110# | 25.55±3.25 | 0.807# | 26.65±2.82 | 0.004#** |
| EOS | 28.02±3.56 | 26.94±3.78 | 25.59±3.14 | 27.27±2.87 | |||||
| Change | 0.59±0.77 | 0.33±0.86 | 0.04±0.76 | 0.62±0.77 | |||||
| MCHC (g/dL) | Baseline | 32.17±0.78 | 0.028#* | 31.69±1.20 | 0.105# | 32.29±1.81 | 0.735# | 31.74±0.74 | 0.012#* |
| EOS | 32.78±1.33 | 32.16±1.63 | 32.15±1.12 | 32.52±1.38 | |||||
| Change | 0.61±1.08 | 0.46±1.18 | −0.14±1.78 | 0.77±1.16 | |||||
| Platelet count (Lakhs/cm2) | Baseline | 2.86±0.60 | 0.610# | 3.27±0.98 | 0.333# | 2.95±0.65 | 0.953# | 2.67±0.76 | 0.682# |
| EOS | 2.80±0.59 | 3.17±1.01 | 2.95±0.67 | 2.73±0.70 | |||||
| Change | −0.06±0.45 | 0.10±0.43 | 0.00±0.27 | 0.05±0.55 | |||||
Notes: Values are mean±standard deviation (SD). #Paired t-test; *p<0.05 and **p<0.01.
Abbreviations: N, number of subjects; Hb, Hemoglobin; WBC, White blood cell; PCV, Packed cell volume; MCV, Mean corpuscular volume; MCH, Mean corpuscular hemoglobin; MCHC, Mean corpuscular hemoglobin concentration; cmm, cubic millimeter; g/dl, gram/deciliter; fL, femtolitres; pg, picograms.