5
Clinical insight
P R O B E
• V o l . L I I I • N o . 3 • A p r – J u n 2 0 1 4
Table 3. Effect of Lukol Syrup on Clinical Parameters
Parameters
At Entry
Week 2
Week 4
Lukol
Syrup
Pulse/min
76.97 ± 3.468 77.83 ± 2.629 78.63 ± 2.734
Significance
NS
a
P
< .01
Temperature (°F)
98.42 ± 0.1562 98.42 ± 0.1562 98.41 ± 0.1367
Significance
NS
NS
Blood Pressure
(systolic)
123.4 ± 6.391 123.7 ± 5.47
121.7 ± 3.824
Significance
NS
NS
Blood Pressure
(diastolic)
76 ± 6.508
76 ± 6.508 78.29 ± 3.824
Significance
NS
NS
Placebo
Pulse/min
77.71 ± 4.233
77.2 ± 4.122 77.49 ± 4.481
Significance
NS
NS
Temperature (°F)
98.44 ± 0.2158 98.49 ± 0.2672 98.41 ± 0.1494
Significance
NS
NS
Blood Pressure
(systolic)
126.2 ± 6.431 124.5 ± 6.532
124 ± 5.531
Significance
NS
a
P
< .05
Blood Pressure
(diastolic)
74.17 ± 8.209 77.31 ± 5.759 77.71 ± 5.044
Significance
a
P
< .05
a
P
< .05
NS, not significant.
Statistical test: Repeated measures of ANOVA with Tukey multiple comparison post
hoc test.
a
Significance at entry level versus week 2 or week 4.
In patients who used Lukol syrup
it showed reduction in leukorrhea
symptoms, summarized in Table
2. The reduction in the symptoms
was seen from day 1 till the end of
the study. There were no clinically
significant adverse reactions, either
reported or observed during the entire
study period and overall compliance
to the treatment was good.
The evaluation of various parameters
on the effect of Lukol syrup has
been evaluated in Table 2. Change
in the values for itching in vulva and
vagina and pain in vulva and vagina
from baseline to each follow up is
considered as there was a statistical
significance at baseline (day 1) for
Lukol syrup versus placebo. For
itching in vulva and vagina, the
change in the value was observed at
week 2 with 1.14 ± 0.43 at week 2 and
1.63 ± 0.65 at week 4. The change in
the level of significance was found to
be
P
< .0362 at week 2 and
P
< .0097
at week 4, respectively. Similarly for
pain in vulva and vagina, the change
in the values were 0.43 ± 0.56 at week
2 and further change in the value at
week 4 was 0.46 ± 0.61. The change in
the level of significance from baseline
to the end of the treatment was found
to be
P
< .0322 and
P
< .0303 at
weeks 2 and 4, respectively. Change
in the value for loss of appetite was
observed with 0.71 ± 0.79 on day 1
with a significance of
P
< .022 in
the Lukol group. Reduction in the
other symptoms of leukorrhea like
painful coitus, backache, constipation,
abdominal pain, and vaginal discharge
was observed from day 1 in the Lukol
group as compared to placebo but
were not found to be statistically
significant.
Evaluation of the effect of Lukol
syrup on clinical parameters is shown
in Table 3. All the parameters were
within the normal limits in both
Lukol and placebo groups at entry
and after the end of the treatment.
Similarly, the effect of Lukol syrup
on hematological and biochemical
parameters is shown in Table 4. All
Table 4. Effect of Lukol Syrup in Hematological and Biochemical Parameters
Parameters
Before Treatment
After Treatment
Significance
(
P
value)
Lukol
Syrup
Hemoglobin
10.10 ± 0.60
10.66 ± 0.55
< .0001
TLC
6254.00 ± 376.80 6363.00 ± 353.20 < .0108
P%
61.11 ± 3.02
62.14 ± 2.12
NS
E%
3.83 ± 1.10
3.49 ± 1.29
NS
B%
0.00 ± 0.00
0.00 ± 0.00
NS
L%
34.14 ± 2.89
33.89 ± 2.25
NS
M%
0.83 ± 0.79
0.43 ± 0.61
< .0141
Platelet Count
2.17 ± 0.41
2.22 ± 0.40
NS
SGPT
22.81 ± 3.89
24.11 ± 1.88
NS
FBS
88.00 ± 5.90
89.66 ± 6.32
NS
Serum Creatinine
0.58 ± 0.13
0.56 ± 0.09
NS
Placebo
Hemoglobin
9.82 ± 0.60
10.01 ± 2.56
NS
TLC
6111.00 ± 1110.00 5817.00 ± 1837.00
NS
P%
61.83 ± 3.48
59.00 ± 14.92
NS
E%
3.57 ± 1.56
3.14 ± 1.46
NS
B%
0.00 ± 0.00
0.00 ± 0.00
NS
L%
33.63 ± 2.91
32.49 ± 9.61
NS
M%
0.71 ± 0.71
0.34 ± 0.54
< .0304
Platelet Count
2.19 ± 0.42
2.15 ± 0.63
NS
SGPT
23.83 ± 3.96
23.49 ± 6.15
NS
FBS
88.26 ± 4.87
86.29 ± 22.41
NS
Serum Creatinine
0.55 ± 0.09
0.54 ± 0.17
NS
NS, not significant; FBS, fasting blood sugar; SGPT, serum glutamic pyruvate
transaminase; TLC, total leukocyte count.
Statistical test: Paired
t
test.
Moharana PK
. Safety and Efficacy of Lukol Syrup
