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Table 3 Clinical and biochemical assessment during follow up

From: Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial

 

Mean ± SD

P1*

P2*

P3*

P4*

Visit ‘0’ (Baseline) Screening

Visit ‘1’ (1 month) CZ 85 mg

Visit ‘2’ (2 months) CZ 250 mg

Visit ‘3’ (3 months) CZ 500 mg

Pulse rate (min−1)

73.4 ± 8.4

71.9 ± 9.2

71.5 ± 8.4

75.8 ± 8.6

NS

NS

<0.05

NS

Systolic Blood Pressure (mmHg)

124.0 ± 10.8

118.0 ± 12.8

117.7 ± 13.2

117.3 ± 11.1

<0.001

NS

NS

<0.01

Diastolic Blood Pressure (mmHg)

76.8 ± 8.4

72.7 ± 11.5

71.9 ± 9.1

72.0 ± 8.2

<0.05

NS

NS

<0.01

Weight (kg)

66.5 ± 11.5

66.5 ± 11.2

66.7 ± 11.6

66.4 ± 11.5

NS

NS

NS

NS

Body Mass Index (kgm−2)

24.8 ± 3.6

24.8 ± 3.5

24.8 ± 3.7

24.7 ± 3.8

NS

NS

NS

NS

Waist circumference (cm)

86.6 ± 10.6

85.5 ± 9.1

85.6 ± 9.4

85.6 ± 8.8

NS

NS

NS

NS

Hip circumference (cm)

97.8 ± 9.0

96.4 ± 8.4

96.2 ± 8.9

96.0 ± 9.3

<0.05

NS

NS

<0.05

Waist to Hip ratio

0.9 ± 0.1

0.9 ± 0.1

0.9 ± 0.1

0.9 ± 0.1

NS

NS

NS

NS

Haemoglobin (g/dl)

14.3 ± 1.6

NM

NM

14.5 ± 1.8

–

–

–

NS

White blood cell count (*109 per mm3)

6.1 ± 0.5

NM

NM

6.3 ± 0.9

–

–

–

NS

Platelet count (*109 per mm3)

202.8 ± 10.7

NM

NM

208.4 ± 18.4

–

–

–

NS

Fasting blood glucose (mg/dl)

91.2 ± 6.9

94.5 ± 11.7

93.0 ± 7.6

92.7 ± 9.6

NS

NS

NS

NS

Serum creatinine (mg/dl)

0.9 ± 0.2

0.9 ± 0.2

0.8 ± 0.2

0.9 ± 0.2

NS

NS

NS

NS

AST (U/l)

27.9 ± 7.3

29.7 ± 7.7

29.2 ± 7.5

27.6 ± 6.3

NS

NS

NS

NS

ALT (U/l)

21.0 ± 10.9

23.4 ± 10.9

21.7 ± 10.5

19.2 ± 11.2

NS

NS

NS

NS

Serum bilirubin (mg/dl)

0.8 ± 0.4

0.6 ± 0.3

0.5 ± 0.4

0.7 ± 0.4

NS

NS

NS

NS

PT/INR

1.1 ± 0.1

1.1 ± 0.1

1.1 ± 0.1

1.1 ± 0.1

NS

NS

NS

NS

Total cholesterol (mg/dl)

226.4 ± 38.7

NM

NM

210.24 ± 50.9

–

–

–

<0.05

LDL cholesterol (mg/dl)

152.8 ± 37.1

NM

NM

129.8 ± 47.4

–

–

–

<0.001

HDL cholesterol (mg/dl)

52.7 ± 14.2

NM

NM

61.8 ± 21.4

–

–

–

NS

VLDL cholesterol (mg/dl)

24.6 ± 15.2

NM

NM

27.6 ± 22.7

–

–

–

NS

Triglycerides (mg/dl)

112.1 ± 49.9

NM

NM

115.0 ± 47.9

–

–

–

NS

  1. ALT Alanine aminotransferase, AST Aspartate aminotransferase, CZ Cinnamomum zeylanicum, HDL High Density Lipoprotein, LDL Low Density Lipoprotein, INR International Normalized Ratio, NM Not Measured, NS Not Significant, PT Prothrombin Time, VLDL Very Low Density Lipoprotein; *P1 – Baseline vs Visit 1; *P2 – Visit 1 vs Visit 2; *P3 – Visit 2 vs Visit 3; *P4 – Visit 0 vs Visit 3