Table 4.

Comparison of biochemical and safety parameters in plasma samples of test and placebo group at day 0, 30 and 60.

	Test Group			Within Group Analysis of Test Group		Placebo		P➔T ** Crossover Group	Within Group Analysis
									Placebo	P➔T ** Crossover Group
	Day 0	Day 30	Day 60	Day 0–30	Day 0–60	Day 0	Day 30	Day 60	Day 0–30	Day 30–60
	Mean + SE	Mean + SE	Mean + SE	p-Value #	p-Value #	Mean + SE	Mean + SE	Mean + SE	p-Value #	p-Value #
Red Blood Cell	4.46 ± 0.08	4.58 ± 0.10	4.49 ± 0.08	0.244	0.755	4.52 ± 0.07	4.56 ± 0.05	4.55 ± 0.10	0.587	0.931
(1012/L)
Hemoglobin (g/dl)	12.98 ± 0.27	13.04 ± 0.29	13.00 ± 0.22	0.792	0.946	12.62 ± 0.32	12.38 ± 0.20	12.49 ± 0.22	0.446	0.567
Hematocrit (%)	44.00 ± 0.85	42.18 ± 1.02	41.34 ± 1.05	0.078	0.021	40.92 ± 1.02	40.78 ± 0.86	41.76 ± 0.84	0.871	0.432
Platelet count (109/L)	248.42 ± 19.20	286.92 ± 21.33	299.25 ± 18.36	0.017	0.009	226.08 ± 12.12	288.08 ± 14.95	301.75 ± 16.56	0.006	0.511
Neutrophil count (cells/mm3)	3611.73 ± 92.30	3930.02 ± 73.19	4089.26 ± 126.28	0.001	<0.001	3658.69 ± 138.22	3624.15 ± 107.61	3561.05 ± 118.30	0.772	0.716
Eosinophil count (cells/mm3)	149.72 ± 6.01	150.10 ± 5.97	155.05 ± 4.84	0.945	0.241	142.69 ± 5.13	141.24 ± 4.11	142.16 ± 5.29	0.846	0.859
Basophil count	55.46 ± 5.84	61.42 ± 6.14	55.67 ± 5.32	0.358	0.969	57.58 ± 5.84	56.38 ± 4.76	58.09 ± 5.69	0.894	0.826
(cells/mm3)
Monocyte count (cells/mm3)	459.25 ± 15.58	457.76 ± 16.11	495.37 ± 14.70	0.899	0.033	464.19 ± 17.59	442.73 ± 14.28	459.03 ± 18.53	0.267	0.532
Leukocytes	5706.67 ± 126.82	5875.81 ± 128.18	6095.51 ± 140.05	<0.001	<0.001	5701.67 ± 138.70	5630.00 ± 115.13	5496.67 ± 162.25	0.087	0.529
(cells/mm3)
Lymphocytes	1830.45 ± 130.18	2297.50 ± 152.05	2656.51 ± 210.26	0.004	0.002	1711.42 ± 46.66	1131.61 ± 95.09	1644.33 ± 132.33	<0.001	0.008
(cells/mm3)
Total Cholesterol (mg/dL)	184.17 ± 7.83	180.67 ± 8.37	171.67 ± 6.88	0.561	0.172	186.83 ± 3.95	168.25 ± 4.11	172.17 ± 4.39	0.009	0.424
Triglycerides (mg/dL)	156.75 ± 5.89	154.68 ± 5.56	150.83 ± 5.77	0.529	0.267	161.00 ± 5.66	151.62 ± 3.59	152.33 ± 4.74	0.077	0.661
LDL Cholesterol (mg/dL)	72.00 ± 3.08	67.58 ± 3.34	63.33 ± 3.31	0.183	0.013	71.75 ± 3.08	67.50 ± 2.66	67.28 ± 1.70	0.035	0.096
VLDL Cholesterol (mg/dL)	32.67 ± 1.32	32.00 ± 1.84	32.36 ± 2.38	0.627	0.883	29.25 ± 1.42	30.28 ± 1.50	27.87 ± 1.52	0.599	0.044
HDL Cholesterol (mg/dL)	32.17 ± 0.84	33.03 ± 0.71	31.08 ± 1.16	0.308	0.469	34.42 ± 4.04	33.03 ± 0.73	32.25 ± 0.66	0.769	0.334
SGOT (U/L)	22.28 ± 1.35	26.25 ± 1.83	26.08 ± 1.07	0.076	0.021	24.00 ± 1.31	27.30 ± 1.52	26.98 ± 1.27	0.079	0.647
SGPT (U/L)	46.20 ± 3.00	51.71 ± 2.43	52.94 ± 2.70	0.115	0.067	48.60 ± 3.82	52.15 ± 3.27	51.33 ± 2.55	0.382	0.711
Blood Urea (mg/dL)	15.32 ± 0.67	15.02 ± 0.69	14.42 ± 0.48	0.499	0.192	14.58 ± 0.87	14.83 ± 0.54	14.95 ± 0.72	0.799	0.792
Serum creatinine (mg/dL)	0.73 ± 0.03	0.56 ± 0.06	0.57 ± 0.05	0.02	0.007	0.72 ± 0.02	0.66 ± 0.06	0.68 ± 0.07	0.408	0.634
Fasting Blood Sugar (mg/dL)	88.17 ± 2.55	88.25 ± 2.55	88.62 ± 2.71	0.984	0.907	90.67 ± 2.60	90.37 ± 2.04	89.19 ± 2.21	0.914	0.561
Systolic Blood Pressure (mm/Hg)	127.08 ± 0.96	126.50 ± 0.89	126.92 ± 0.75	0.669	0.845	128.25 ± 1.56	127.75 ± 1.02	126.92 ± 0.84	0.784	0.372
Diastolic Blood Pressure (mm/Hg)	84.42 ± 1.18	84.67 ± 0.88	85.33 ± 1.09	0.891	0.613	83.92 ± 1.50	85.67 ± 0.87	85.50 ± 1.00	0.358	0.883
Pulse rate (beats/min)	74.25 ± 1.90	71.75 ± 1.15	73.42 ± 1.29	0.106	0.493	75.58 ± 1.11	74.83 ± 1.05	72.42 ± 0.82	0.529	0.092
Temperature (°C)	36.74 ± 0.11	36.63 ± 0.09	36.53 ± 0.09	0.463	0.138	36.79 ± 0.13	36.64 ± 0.12	36.41 ± 0.07	0.523	0.14

^# Within group significance using the t-test (equal variances). ** Placebo group crossed over to the test group in the extension study period.