2
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
Muralikumar V.
Safety and efficacy of Diarex Syrup
Aim
The aim of the study was to evaluate
the safety and efficacy of Diarex syrup
in children suffering from diarrhea.
Material andMethods
Twenty children presenting with loose
stools of varied etiology were included
in this study.
Parents of all the enrolled children
were given detailed description about
the investigational product and
duration of the study. Also, children’s
responsibilities after entering the
study were explained. Children
were prescreened by the investigator
for the criteria indicated in the
subject selection section. Only those
individuals who met the requirements
of this section have signed an
informed consent form (by the parent/
guardian), children or parents and
guardian who were ready to follow
instructions given by the investigator
and have an updated medical history
on file with the investigator were
included in the study.
The enrolled children were advised
totake Diarex syrup orally at a dosage
of:
• 7.5 mL thrice daily for 7 days for
children aged 3 to 5 years
• 15 mL thrice daily for 7 days for
children aged 6 to 10 years
Children were evaluated for safety and
efficacy at the end of day 3 and day 7.
The children were evaluated for any
presenting complaints and underwent
general physical examination at all the
visits. The children were followed up
on day 3 and day 7. The children were
advised to report immediately for any
side effects they experienced during
the therapy with Diarex. No other
medications except oral rehydration
therapy were given to the patients.
Results
The demographic details of the
children at entry are shown in
Table 1. The age of the included
children at entry was 6.2 ± 2.6 years,
mean weight 18.9 ± 8.2 kg. There were
13 males and 7 females in the study
and the duration of diarrhea was 2.4 ±
1.2 days.
Table 1. Demographic Data At Entry
Parameter
Diarex (n = 20)
Age (years)
6.2 ± 2.6
Mean Weight (kg)
18.9 ± 8.2
Sex Ratio (M:F)
15:7
Duration of Diarrhea
(days)
2.4 ± 1.2
Of the 20 children who entered the
study, 19 children completed the
treatment; 1 child was lost to follow
up. Diarex syrup showed significant
improvement in the symptoms from
third day onward and was beneficial
in children suffering from diarrhea
(Table 2).
Table 2. Symptom Evaluations Before and
After Diarex Therapy
Parameter
Duration
No. of
Children
Presenting
With
Symptoms
Loose Stools
At entry
20
Day 3
7
Day 7
2
*
Normal
Stool
Consistency
At entry
0
Day 3
12
Day 7
18
*
Nausea
At entry
8
Day 3
3
Day 7
0
*
Vomiting
At entry
5
Day 3
1
Day 7
0
*
P
< .001
Statistical analysis: Fisher exact test
At entry all children presented
abnormal stool consistency, which
reduced in 7 children on day 3 and
further reduced to 2 children on day 7
with a significance of
P
< .001. On day
3, 12 children presented with normal
stool consistency, which further
improved to 18 patients on day 7 with
a significance of
P
< .001. Nausea was
evident in 8 patients at entry which
reduced to 3 patients on day 3 and
further after continued treatment with
Diarex, no children presented with
nausea on day 7 with a significance
of
P
< .001. Five children presented
with vomiting at entry, which after
treatment with Diarex reduced to
1 child on day 3 and after further
treatment no children presented with
symptoms of vomiting on day 7. The
study results indicate that Diarex
significantly decreased most of the
symptoms of diarrhea from day 3
onward and it continued till the end
of the study. There were no adverse
effects either observed or reported in
the study and compliance to the drug
treatment was adequate.
Conclusion
This clinical study demonstrates
that Diarex syrup is beneficial in
individuals suffering from diarrhea.
The clinical parameters like diarrhea,
stool consistency, nausea, and
vomiting showed improvement
from day 3, and showed further
improvement until the end of the
study. There were no adverse effects
either reported or observed during
the study period. This formulation is
well tolerated and safe in the dosage
used. Therefore, it can be concluded
that Diarex syrup is beneficial in
individuals suffering from diarrhea.
