Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa: Design 3+3 Phase I Clinical Trial

Table 2

Effects of P2Et extract on biochemical parameters and hematological parameters in rats following 28 days of administration.

	Parameters (reference values)	Group		value
		Test (N = 10)	Control (N = 10)
Kidney function	Urea (18.0 to 45.0 mg/dL)	46.42 ± 7.04	49.15 ± 4.64	0.53
	Creatinine (0.05 to 0.65 mg/dL)	0.28 ± 0.03	0.29 ± 0.04	0.54
	Sodium (135.0 to 146.0 mmol/L)	144.47 ± 1.74	144.27 ± 4.09	0.52
	Potassium (4.0 to 5.9 mmol/L)	6.487 ± 0.55	7.87 ± 0.98	0.48
	Chloride (96.0 to 107.0 mmol/L)	103.63 ± 1.62	99.66 ± 3.12	0.60
	Calcium (5.3 to 11.6 mg/dL)	10.70 ± 0.63	10.99 ± 0.75	0.73
Liver function	ALT (20 to 61 U/L)	59.30 ± 10.89	78.2 ± 12.29	0.12
	Phosphatase (16 to 302 U/L)	214.90 ± 54.03	300.30 ± 91.81	0.08
	AST (39.0 to 111.0 U/L)	123.30 ± 14.79	209.00 ± 71.43	0.16
	GGT (0 to 6 U/L)	4.20 ± 0.63	4.40 ± 0.97	0.70
	Bilirubin (0.1 to 0.7 mg/dL)	0.34 ± 0.14	0.54 ± 0.10	0.61
	Cholesterol (20 to 92 mg/dL)	5.92 ± 0.43	6.28 ± 0.42	0.70
	Triglycerides (27 to 108 mg/dL)	111.28 ± 46.38	116.65 ± 25.88	0.24
Erythrogram	Erythrocytes (5.1 to 7.9 millions/mm^3)	6.06 ± 0.63	6.06 ± 0.75	0.76
	Hemoglobin (10.0 to 17.4 g/dL)	13.36 ± 1.05	12.98 ± 1.13	0.45
	Hematocrit (33.0 to 50.0%)	42.16 ± 2.74	40.80 ± 3.05	0.88
	MVC (57.8 to 66.5 u3)	64.94 ± 2.40	67.83 ± 5.95	0.87
	MHC (17.1 to 23.5 pg)	20.54 ± 0.67	21.55 ± 1.45	0.49
	MCHC (29.0 to 37.0 g/dL)	31.68 ± 1.04	31.85 ± 2.07	0.33
	Total protein (5.4 to 8.5 g/dL)	5.92 ± 0.33	6.10 ± 0.45	0.38
Leukogram	Leukocytes (5.2 to 12.5 thousands/mm^3)	4.48 ± 1.15	5.95 ± 2.01	0.33
	Neutrophil (20 to 75%)	55.60 ± 17.10	63.67 ± 7.89	0.46
	Eosinophil (1 to 4%)	0.00 ± 0.00	0.17 ± 0.41	0.19
	Lymphocytes (30 to 85%)	41.80 ± 18.05	33.00 ± 8.15	0.30
	Monocytes (1 to 4%)	2.60 ± 1.14	3.17 ± 1.47	0.11
	Platelets (250 to 650 thousands/mm^3)	418.60 ± 102.50	473.67 ± 76.62	0.52
Coagulogram	PT (7.2 to 7.8 seconds)	7.44 ± 0.32	7.35 ± 0.26	0.44
	PTT (35 seconds)	21.38 ± 1.09	22.73 ± 2.23	0.38

N: number of animals in the group; data expressed as mean ± standard deviation. ∗Statistically significant difference  < 0.05.