MINISTRY OF HEALTH OF THE REPUBLIC OF UZBEKISTAN
SPECIALIZED SCIENTIFIC-PRACTICAL
CENTER OF PEDIATRICS OF MINISTRY OF HEALTH OF REPUBLIC OF UZBEKISTAN
TASHKENT 2011
REPORT OF CLINICAL TRIAL OF “INSTY FOR KIDS” PRODUCED BY
“HERBION PAKISTAN Pvt Ltd“
PURPORSE OF TRIAL:
To study the efficacy and
safety of “Insty for kids” included in complex therapy for children
patients suffering from Acute Respiratory Infections (ARI).
STUDY
OBJECTIVE:
COMPONENTS OF
DRUG:
Form: Granules.
Composition:
One
sachet contains active ingredients - thick extracts
|
Ingredient |
Amount |
|
Salix alba |
468 mg |
|
Adhatoda vasica |
188 mg |
|
Viola odorata |
62 mg |
|
Glycyrrhiza glabra |
344
mg |
|
Thea sinensis |
78
mg |
|
Foeniculum vulgare |
47
mg |
|
Eucalyptus globulus |
22
mg |
|
Valeriana officinalis |
63
mg |
Supportive
ingredients: Flavor "tutti-frutti, corn starch, sucrose
PHARMACOLOGICAL ACTIVITY:
Insty
granules – complex herbal product with anti cold, expectorant,
mucolytic, broncholytic,
antipyretic and spasmolytic effects. Insty diminishes symptoms of
intoxication (hyperthermia,
sweating, weakness), accompanying
inflammatory processes of the upper and lower respiratory tract,
antiseptic effect, reduces intensity and enhances cough productivity.
Insty significantly improves
condition of the patients, reduces fever and cough intensity. Contributes to the rapid elimination of symptoms of rhinitis,
pharyngitis, tracheitis within 24 hours after use.
Insty for Kids does
not cause drowsiness and addiction. It rapidly dissolves in hot water.
|
INGREDIENT |
MEDICINAL
PROPERTIES |
|
Salix alba |
Contains
glycoside salicin,
tremulatsin. Has an antipyretic,
anti-inflammatory, analgesic effect. |
|
Adhatoda vasica |
Contains
alkaloids vazitsin, vazitsinon. Has bronchodilatory, expectorant effects,
enhances the mobility of the cilia of the bronchial epithelium and
accelerates the discharge of phlegm, has anti asthmatic effect. |
|
Viola odorata |
Contains Violin, fridelin &
essential oils. Has antihistamine, expectorant, antipyretic, diaphoretic
effects. |
|
Glycyrrhiza glabra
|
Contains glycoside glycyrrhizin,
flavonoids, asparagine. Have a significant
expectorant, immunostimulanting and anti-inflammatory action. Exerts
inhibitory effect on the exudative and proliferative phases of inflammation. |
|
Thea sinensis |
Contains tannin, caffeine & theophylline.
Has viscous, tonic & diuretic effects. |
|
Foeniculum vulgare |
Contains essential oils, dipentin. Enhance
the
secretor function of the bronchi and has mucolytic action, and also has
antiseptic and anti-inflammatory properties. |
|
Eucalyptus globulus |
Contains essential oils (cineole,
pinene, mirtenol, pinokarvon, eydesmol), tannins. Has strong antiseptic
effects, especially for streptococci, staphylococci, causes anti-inflammatory
effects. Stimulates regeneration processes, Increases the resistance of
tissues to hypoxia |
|
Valeriana officinalis |
Contains essential oils (isovaleric
acid, valerena, borneol, a-pinene), alkaloids
(valerian, hatinin), saponins, ketones. Exerts multilateral effects on the
organism, decrease central nervous system excitability, and
reduces severity of headache & cough. |
METHOD:
Trials were conducted in the Pediatric
Department of Pulmonology of Specialized Scientific-Practical Center of
Pediatrics of Uzbekistan, on 46 patients (14 children aged 6 months to 1 year
and 32 children aged 1 year to 6 years)
The product was administered
depending on the child's age (1/2 sachet 2 times a day for children 6 months to
1 year; 1 sachet 2 times a day for children from 1 to 6 years within 7 days).
In the trials, for evaluation of
treatment effects of the product used method of questionnaire. Before starting
of the treatment questionnaire was recorded. Further questionnaire were filled
in the mid of the treatment course which observed the appeared changes as well
at the end of the treatment course.
At the time of
the administration of Insty for kids regular functional checkup
of the children patients was conducted.
Parallel observation conducted
for the reference group of 25 children with ARI not treated with Insty for
kids.
During trial clinical
effectiveness was analyzed by dynamic changes of character and intensity of cough,
by rate of relief of broncho obstructive syndrome. Clinical monitoring
conducted for the entire period of illness, with regular (not less than 1 time
per 3 days) observation. in this case obligatory for evaluation of analyzed parameters and their
recording in “individual observation form” are
<< 0 visits>>
at
inclusion in the trials <<1
visit>> at
3rd day of the treatment <<
2nd visit>> at 5 th day of the treatment and
<<3 rd
visit>> at 7 th day of the treatment.
Tolerance of the drug was
assessed by frequency of occurrence of undesired and side effects.
After completion
of the trials statistical evaluation of obtained results was conducted and recorded
in <<case report form>> of observations.
RESULTS OF TRIAL
During observation attention was
paid to appearance and duration of the disease symptoms of illness: body temperature
reaction, intoxication symptoms,
and catarrhal effects in
nasopharynx and changes in lungs (identified physically).
When such symptoms were found out children were hospitalized.
During collection of anamnestic
data revealed that all the children during previous year suffered from ARI for more
than 4-5 times. Duration of cough and respiratory infection averaged around 16
days. 95% of patients had fever, mild intoxication (malaise, decreased
appetite, headache, etc.) in 83% of patients, catarrhal effects in 78% and
productive cough in 54% of patients. During respiratory infection 45% of
children observed with increased respiration, rigid breathing on auscultation
observed in 93% of children, exacerbation of chronic infections (chronic
tonsillitis, sinusitis) in 44% and conversion
to severe pneumonia observed in 24% of
the
children.
Most of the children included in
the study were with established ARI, complicated acute obstructive bronchitis
(45%). At the time of inclusion in the study bronchial obstruction in 90% of
the children manifested mild expiratory wheezing. Particularly noteworthy to
bring into attention that at the time of inclusion in the study children were
noted with nonproductive cough 35%, fever 38.9%, runny nose 29,3% and lacrimation
42,1%.
Leukocytes in the blood of ill
children were 11,5 ± 0,8x 109/L,
Lymphocytes 68±0,7% and ESR 6,5 ± 6,1
mm / hr.
During administration of “Insty
for kids” within 7 days in adequate dose objectively reduced clinical
manifestations of ARI proceeding with symptoms of tracheitis or tracheobronchitis.
By day 5 cough disappeared in 11 sick children, improved overall health, mood
and decreased nasal congestion, fever disappeared by day 7 and cough disappeared
in almost all the patients. Results of the study appear in Tables 1, 2, 3.
TABLE 1.
AVERAGE DURATION OF SYMPTOMS FLOW IN CHILDREN WITH ARI
DURING THE
TREATMENT WITH “INSTY FOR KIDS”.
|
Symptoms |
Duration of symptoms in days |
|||
|
Decrease in clinical manifestations |
Recovery |
|||
|
Study group |
Refence group
|
Study group |
Reference
group |
|
|
Cough |
3,7±0,1 |
6,6±0,03 |
6,2±0,02 |
9,4±0,1 |
|
Rise in temperature
|
5,6±0,02 |
7,2±0,3 |
7,1±0,1 |
9,4±0,2 |
|
Runny nose
|
3,8±1,1 |
6,1±1,1 |
5,0±0,09 |
7,2±1,2 |
|
Lacrimation
|
2,9±1,02 |
5,8±1,02 |
5,1±0,04 |
6,9±1,1 |
|
Headache
|
2,5±0,09 |
5,2±0,4 |
4,8±1,01 |
6,8±0,08 |
As shown in table 1 children
taking product Insty for kids
considerably quickly
stopped dry cough, decreased catarrhal symptoms as compared to reference group.
The study revealed
that use of Insty for kids resulted in significant reduction in the severity and
duration of basic clinical manifestations of ARI. Thus, in the duration of study:
-
fever decreased from 5,3 ± 0,4 to 2,6 ± 0,1 days;
-
intoxication -
from 4,6 ± 1 to 2,4 ± 0,5 days;
-
runny nose - from 6,8 ± 0,3 to 3,8 ± 0,3 days;
-
cough - from 9,9 ± 0,3 to 7 ± 0,2 to days
TABLE 2.
THE DYNAMICS OF REDUCTION OF CLINICAL MANIFESTATIONS
DURING THE TREATMENT WITH “INSTY FOR KIDS”
|
Symptoms
|
Day 2-3
|
Day 5
|
Day 7
|
|
Number of children (from
% of total patients) |
|||
|
Cough
|
9 (19,6%) |
18 (39,1%) |
2 (4,3 %) |
|
Rise in temperature
|
23 (50%) |
6 (13%) |
- |
|
Runny nose
|
10 (22%) |
8 (17,4%) |
1 (2,2%) |
|
Lacrimation
|
12 (26%) |
2 (4,3%) |
- |
|
Headache
|
14 (30,4%) |
4 (8,7%) |
- |
Analyzing Table 2,
shows that basic improvements occurred by day 3 - 5 of visits. Catarrhal
symptoms improvement occurred by day 3 - 5 of treatment.
TABLE 3:
THE DYNAMICS OF RECOVERY AT THE
TREATMENT WITH “INSTY FOR KIDS”
|
symptoms |
Day 2-3 |
Day 5
|
Day 7
|
|
Number of children (from
% of total patients) |
|||
|
cough |
11 (24%) |
8 (17,4%) |
3 (6,5 %) |
|
Rise in temperature
|
15 (32,6%) |
3 (6,5%) |
1 (2,17%) |
|
Runny nose
|
10 (21,7%) |
8 (26,6%) |
- |
|
Lacrimation
|
11 (24%) |
3 (6,5%) |
- |
|
Headache
|
9 (19,6%) |
2 (4,3%) |
- |
Table 3 shows that
recovery of the children with ARI occurred mostly by day 5 - 7
SIDE EFFECTS:
In particular
noted
that undesired & side effects during treatment in children were not observed.
Administration of Insty for kids did not cause complaints among children and their
parents. Overall tolerance was rated as good.
RESULTS DEBATE
Considering obtained clinical results: earlier decrease
in clinical symptoms of ARI as compared
to reference group and fast recovery,
it can be concluded that the product "Insty
for kids" is quite effective for the treatment of acute inflammatory diseases of
upper respiratory tract infections in children including obstructive bronchitis.
Thus, the conducted study led to the
conclusion that a comprehensive herbal product Insty for kids with
anticold effects has a high clinical efficacy and good tolerance in the treatment
of children with ARI and obstructive bronchitis.
CONCLUSIONS AND SUMMARY
The product Insty
for kids has pronounced therapeutic effects in children with acute upper respiratory
tract diseases and can be recommended for children from 6 months of age for the
treatment of ARI with symptoms of tracheitis, bronchitis and chronic obstructive
bronchitis. In the
treatment of children with ARI and flu recommends in complex therapy inclusion
of Insty for kids.
The product should
be prescribed for children aged 6 months to 1 year 1 / 2 sachet 2 times a day and
for children from 1 to 6 years 1 sachet 2 times a day within 7 days. The product
should be prescribed for children aged 6 months to 1 year 1 / 2 sachet 2 times a
day and for children from 1 to 6 years 1 sachet 2 times a day within 7 days.
LITERATURE: