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

Table 3

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

	Parameters and reference values	Group		value
		Test (N = 5)	Control (N = 6)
Kidney function	Urea (13.0 to 52.0 mg/dL)	42.32 ± 11.91	43.68 ± 6.98	0.66
	Creatinine (0.80 to 1.80 mg/dL)	1.34 ± 0.46	1.19 ± 0.33	0.91
	Sodium (138.0 to 148.0 mmol/L)	142.48 ± 1.18	144.35 ± 3.76	0.93
	Potassium (3.3 to 6.9 mmol/L)	4.81 ± 0.46	4.78 ± 0.47	0.55
	Chloride (92.0 to 112.0 mmol/L)	99.64 ± 2.55	98.38 ± 4.56	0.58
	Calcium (5.6 to 12.0 mg/dL)	12.86 ± 0.32	12.88 ± 0.41	0.93
Liver function	ALT (31 to 60 U/L)	162.00 ± 111.60	108.17 ± 21.21	0.62
	Phosphatase (90 to 145 U/L)	145.00 ± 32.52	137.33 ± 44.53	0.50
	AST (42.0 to 98.0 U/L)	103.80 ± 95.05	95.50 ± 53.78	0.65
	GGT (4 to 12 U/L)	6.20 ± 2.49	6.00 ± 1.67	0.81
	Bilirubin (0.30 to 0.80 mg/dL)	0.44 ± 0.07	0.53 ± 0.10	0.23
	Cholesterol (35 to 60 mg/dL)	44.00 ± 0.00	43.67 ± 0.52	0.26
	Triglycerides (124 to 156 mg/dL)	108.34 ± 75.81	76.17 ± 37.28	0.81
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.