6
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 5. Effect of Lukol Syrup on Microbiological Examination
Before
Treatment
C albicans
Present
Absent
Significance
(
P
value)
Lukol
25
10
NS
Placebo
27
8
T vaginalis
Lukol
26
9
NS
Placebo
30
5
After
Treatment
C albicans
Present
Absent
Significance
Lukol
8
27
NS
Placebo
16
19
T vaginalis
Lukol
7
28
< .0224
Placebo
17
18
NS: Not significant.
Statistical test: Fisher exact test.
Table 6. Overall Impression
Patient
By Investigator
Overall Response to Lukol Syrup
Therapy
No.
Percentage
Response
No.
Percentage
Response
Cured = 1
3
8.57
5
14.29
Marked Improvement = 2
16
45.71
16
45.71
Moderate Improvement = 3
11
31.43
12
34.29
Slight Improvement = 4
5
14.29
2
5.71
No Change = 5
0
0.00
0
0.00
Symptoms Became Worse = 6
0
0.00
0
0.00
Total
35
100
35
100
Patient
By Investigator
Overall Response to Placebo
No.
Percentage
Response
No.
Percentage
Response
Cured = 1
0
0.00
0
0.00
Marked Improvement = 2
1
2.86
2
5.71
Moderate Improvement = 3
12
34.29
12
34.29
Slight Improvement = 4
4
11.43
5
14.29
No Change = 5
12
34.29
12
34.29
Symptoms Became Worse = 6
6
17.14
4
11.43
patient showed marked improvement,
12 patients showed moderate
improvement, 4 patients showed slight
improvement, 12 patients showed no
change and for 6 patients symptoms
became worse. The investigator
response to the treatment had shown
that in the Lukol group, 5 patients
were cured, 16 patients showed
marked improvement, 12 patients
showed moderate improvement, and
2 patients showed slight improvement
to treatment. Whereas, in the placebo
group the investigator response to
the treatment showed 2 patients with
marked improvement, 12 patients with
moderate improvement, 5 with slight
improvement, 12 showed no change,
and 4 patients with symptoms became
worse at the end of the treatment.
In a series of 70 cases of leukorrhea,
oral treatment with Lukol syrup
gave good results with significant
reduction of symptoms within 2
weeks of treatment. Lukol syrup was
well tolerated and produced no toxic
effects. Two patients from the placebo
group were withdrawn from the study
due to personal reasons. There were
no adverse effects either observed or
reported during the clinical study and
overall compliance to treatment was
found to be good.
Discussion
White discharge or leukorrhea is
a common complaint in clinical
practice. The common causes of
leukorrhea include vaginal infection
with
T vaginalis
,
C albicans,
or mixed
bacteria. Very often a causative agent
is not found. Another important cause
is postmenopausal vaginitis, which
is treated with hormone replacement
or by use of vaginal creams. Vaginal
infections are treated with proper
antibiotics. But in most of the cases,
leukorrhea persists or recurs.
the parameters were found to be
within the normal limits before and
after treatment in both the groups.
Microbiological evaluation of the
effect of Lukol syrup before and
after treatment is shown in Table 5.
Candida albicans
was present in 25
patients before treatment in Lukol
group whereas, in the placebo group,
C albicans
was present in 27 patients
before treatment. After 4 weeks of
treatment with Lukol syrup, there was
marked reduction in the number of
patients with only 8 patients having
C albicans
; however, the significance
was missing in the Lukol group.
In the placebo group, 16 patients
still persisted with
C albicans
after
treatment. Similarly,
Trichomonas
vaginalis
was present in 26 patients
in the Lukol group and 30 patients in
the placebo group before treatment.
At the end of treatment, there was a
significant (
P
< .0224) reduction with
only 7 patients having
T vaginalis
in the Lukol group as compared to
placebo.
Overall impression to the treatment
was evaluated by interviewing the
patient and is presented in Table
6. Out of 35 patients, 3 patients
were cured, 16 showed marked
improvement, 11 showed moderate
improvement and 5 patients showed
slight improvement to Lukol syrup.
Whereas, in the placebo group, 1
Moharana PK
. Safety and Efficacy of Lukol Syrup
