4
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
Moharana PK
. Safety and Efficacy of Lukol Syrup
is very common and is seen when the
discharge originates in the vagina.
Most probably it is due to disturbances
of estrogenic function caused by
ovarian insufficiency.
Aim
This study was planned to evaluate
the clinical efficacy and safety of
Lukol syrup in relieving symptoms
associated with leukorrhea.
Materials andMethods
Seventy women, 30 years and
older, with symptoms of leukorrhea
attending the outpatient Department
of Internal Medicine, SJS Ayurvedic
Medical College, (Nazarathpet,
Chennai, Tamil Nadu, India) were
included in the study. Detailed history
was obtained and general examination
of the patients was carried out to
exclude patients suffering from
systemic disorders. Also those
with pre-existing systemic disease
necessitating long-term medications,
endocrinal disorders, patients with
known history or present condition
of allergic response to similar
medications and those who refused to
give informed consent were excluded
from the study. Pregnant and lactating
women were also excluded from the
study. Pelvic examination was done to
exclude pelvic pathology. Speculum
examination was done to exclude
lesions of the cervix and vagina
and the discharge was examined
microscopically to rule out specific
cervicitis or vaginitis. Pap smear was
done on patients aged 35 and more to
exclude early malignancy.
All the enrolled women were
randomized to Lukol group and
placebo group using random number
table. Patients in the Lukol group
received Lukol syrup at a dosage of 2
teaspoonfuls twice daily for 4 weeks
and patients in the placebo group
received similar looking placebo
at the same dose for 4 weeks. All
patients were followed up at weeks 2
and 4 for the presence or absence of
symptoms. The predefined primary
efficacy endpoint was relief from the
symptoms of leukorrhea. Assessment
parameters included itching in vulva
and vagina, pain in vulva and vagina,
painful coitus, backache, loss of
appetite, constipation, weakness,
abdominal pain, and vaginal
discharge.
Results were analyzed statistically by
Mann Whitney test for evaluation
of Lukol syrup in symptoms of
leukorrhea. Effect of Lukol syrup for
the evaluation of clinical parameters
were analyzed statistically using
repeated measures of ANOVA with
Tukey multiple comparison post hoc
test and the effect of Lukol syrup
for the evaluation of hematological
and biochemical parameters were
Table 2. Efficacy of Lukol Syrup in Symptoms of Leukorrhea
Parameters
Duration
Lukol Syrup
Placebo
Significance
(
P
value)
Itching in Vulva
and Vagina
Week 2
1.14 ± 0.43 0.82 ± 0.46
< .0362
Week 4
1.63 ± 0.65
1.17 ± 0.62
< .0097
Pain in Vulva
and Vagina
Week 2
0.43 ± 0.56 0.11 ± 0.32
< .0322
Week 4
0.46 ± 0.61 0.11 ± 0.32
< .0303
Painful Coitus
Day 1
0.00 ± 0.00 0.06 ± 0.24
NS
Week 2
0.00 ± 0.00 0.06 ± 0.24
NS
Week 4
0.00 ± 0.00 0.00 ± 0.00
NS
Backache
Day 1
0.77 ± 0.77 0.71 ± 0.86
NS
Week 2
0.23 ± 0.55 0.29 ± 0.46
NS
Week 4
0.14 ± 0.49 0.14 ± 0.36
NS
Loss of Appetite
Day 1
0.71 ± 0.79 1.17 ± 0.75
< .022
Week 2
0.20 ± 0.41 0.26 ± 0.44
NS
Week 4
0.06 ± 0.24 0.09 ± 0.28
NS
Constipation
Day 1
0.57 ± 0.70 0.46 ± 0.78
NS
Week 2
0.06 ± 0.24 0.17 ± 0.38
NS
Week 4
0.00 ± 0.00 0.17 ± 0.38
NS
Weakness
Day 1
0.94 ± 1.06 0.77 ± 0.97
NS
Week 2
0.20 ± 0.41 0.17 ± 0.51
NS
Week 4
0.00 ± 0.00 0.17 ± 0.51
NS
Abdominal Pain
Day 1
0.14 ± 0.36 0.31 ± 0.58
NS
Week 2
0.00 ± 0.00 0.00 ± 0.00
NS
Week 4
0.00 ± 0.00 0.14 ± 0.36
NS
Vaginal
Discharge
Day 1
0.71 ± 1.18
1.14 ± 1.33
NS
Week 2
0.54 ± 0.95 0.63 ± 0.88
NS
Week 4
0.20 ± 0.41 0.46 ± 0.70
NS
NS, not significant.
Statistical test: Mann Whitney test.
Note: Change in the values from baseline to each follow up for symptoms of itching
and pain in the vulva and vagina is considered as there was a statistical significance at
baseline (day 1) for Lukol syrup versus placebo.
evaluated using paired
t
test. For
the evaluation of Lukol syrup
on microbiological examination,
statistical analysis was conducted
using Fisher exact test. There was
95% confidence interval with 5%
level of significance for two-tailed
P
value. Analysis was performed using
GraphPad prism software version 4.03
for Windows (San Diego, CA, USA).
Results
A total of 70 women were enrolled in
the study. The demographic details of
the patients at entry are listed in
Table 1.
Table 1. Demographic Data At Entry (n=70)
Lukol Syrup Placebo
Patients
35
35
Age (mean ±
SD)
31.35 ±
2.65
34.62 ±
7.02
