Safety and Efficacy of Ferula asafoetida in Functional Dyspepsia: A Randomized, Double-Blinded, Placebo-Controlled Study
Table 5
Results of safety evaluation studies.
Parameters
Intergroup comparison based on independent sample t-test
Inner group comparison based on paired sample t-test
Mean difference comparison of variables using independent sample t-test
Time of Observation
Placebo
Asafin
Groups
Baseline
End of Study
Mean difference
p-value
Hb (g/dl)
Baseline End of study
13.25±0.49 13.20±0.47
13.45±0.46 13.78±0.49
Placebo Asafin
13.26±0.17 13.45±0.15
13.20±0.82 13.78±0.20
0.06±0.04 0.33±0.05
0.219
RBC Count (million/µL)
Baseline End of study
4.24±0.15 4.25±0.16
4.26±0.15 4.25±0.15
Placebo Asafin
4.25±0.37 4.26±0.06
4.25±0.33 4.26±0.04
0.009±0.02 0.003±0.02
0.940
Packed cell volume (%)
Baseline End of study
38.30±0.36 38.82±0.36
39.22±0.45 39.88±0.40
Placebo Asafin
38.31±0.42 39.22±0.50
38.82±0.38 39.88±0.47
0.50±0.13 0.66±0.18
0.261
Mean corpuscular volume (fl/red cell)
Baseline End of study
90.60±0.22 91.02±0.25
91.82±0.24 92.92±0.23
Placebo Asafin
90.61±0.84 91.83±0.56
91.02±0.88 92.93±0.47
0.40±0.12 1.09±0.25
0.067
Mean corpuscular haemoglobin (pg/cell)
Baseline End of study
31.32±0.13 31.25±0.48
31.52±0.27 31.71±0.19
Placebo Asafin
31.33±0.24 31.52±0.20
31.25±0.23 31.71±0.13
0.07±0.22 0.09±0.17
0.813
Mean corpuscular haemoglobin Concentration (g/dl)
Baseline End of study
34.42±0.25 34.09±0.22
34.32±0.18 34.24±0.17
Placebo Asafin
34.42±0.18 34.33±0.20
34.09±0.21 34.24±0.23
0.33±0.05 0.08±0.13
0.477
SGOT (IU/L)
Baseline End of study
25.46±0.93 26.28±0.93
27.18±0.93 25.65±0.90
Placebo Asafin
25.46±1.00 27.18±1.20
26.28±0.75 25.66±1.07
0.82±0.15 1.52±0.18
0.771
SGPT (IU/L)
Baseline End of study
33.27±1.22 38.71±0.93
35.14±1.21 33.65±1.17
Placebo Asafin
33.28±0.94 35.14±1.74
38.71±0.96 33.66±1.39
5.43±0.25 1.48±0.11
0.001
ALP (IU/L)
Baseline End of study
85.32±2.97 95.53±2.33
89.92±2.10 95.11±2.32
Placebo Asafin
85.32±2.12 89.92±2.50
95.53±2.07 95.11±2.57
10.20±0.52 5.19±0.30
0.027
S. Creatinine (mg/dl)
Baseline End of study
0.77±0.02 0.81±0.02
0.82±0.02 0.76±0.02
Placebo Asafin
0.78±0.02 0.81±0.02
0.81±0.02 0.77±0.02
0.02±0.001 0.061±0.01
0.006
Values are expressed as mean ± SEM. Hb: haemoglobin, RBC: red blood cells, SGOT: serum glutamic oxaloacetic transaminase, SGPT: serum glutamic pyruvic transaminase, ALP: alkaline phosphatase and S.Creatinine: serum creatinine. Within group comparison was done using paired sample t-test and between group comparisons were done with independent sample t-test. Mean difference comparison of variables was performed by independent sample t-test. P value is also provided.
