HEALTH WITH LIGHT

Medical test record on Doctot Light

 

MEDICAL TEST RECORDS

 

Physiotherapeutic light-emitting diode device (PL-EDD) “DOCTOR SVET”

Moscow

Tests conducted on: 24.04.07-12.06.07

Test subject: Physiotherapeutic light-emitting diode device (PL-EDD) “DOCTOR SVET” (50 units).

 Manufacturer: JSK“AVERS”, 101 819, Moscow. Furkasovsky lane, 3.

 Basis for test: As per records N1, dated 21.04.07, regarding the commission of medical equipment, devices and instruments used in pediatrics, obstetrics and gynecology, from Committee on New Medical Technology.

 Testing purpose: To establish clinical efficiency of the product.

 Results: Ref. Appendix N1 (7 pages).

Supervisor of medical tests: Korovina N.A.

Members of medical test team: Ovsyannikova E.M.

Report

of clinical tests regarding efficiency and safety of the portable physiotherapeutic device “Doctor Svet” for treatment of ARVI in infants

Aim: In a blind random study, conducted at the Department of Pediatrics RMAPO, clinical efficiency and safety for the portable physiotherapeutic device “DOCTOR SVET” were evaluated on infants with acute respiratory viral infections.

Materials and methods

  1. Test subjects – infant patients with acute respiratory viral infections, including those with or without: fever, rhinitis and/or hyperemia of the throat.

  2. Age of test subjects: infants from 1 month to 3 years of age.

  3. Number of test subjects: 60 children, allocated in the following manner:

  • 50 children (experimental group) were administered complex therapy, including antipyretics when necessary. All children were treated using the “DOCTOR SVET” device. Of the 50 children, 6 required antibacterial treatment upon clinical admission, with a diagnosis of acute medial catarrhal otitis. All 6 patients also had symptoms justifying application of the “DOCTOR SVET” device, including: rhinitis, blocked nose, and expressed hyperemia of the throat. Treatment with “DOCTOR SVET” was used in conjunction with antibiotic treatment.

 

  • 10 children (control group), where given complex therapy for treatment of acute respiratory viral infections, without application of “DOCTOR SVET”.

 

Test Progress

Patients were allocated into either the experimental or control groups by random selection. Written consent forms were completed by the parents of the patients (on the patients’ behalf). Parents of the children allocated to the experimental group were issued the “DOCTOR SVET” devices, with instructions for use. Daily examinations were conducted and records of observed symptoms, application compatibility, and allergic reactions recorded on a standardized form. Upon patient recovery, observations ceased and the results were recorded on the form. 

Statistical Analysis of the Experiment

The 50 patients in the experimental group were further divided into three groups according to age: children under 1 year, from 1 to 2 years, and children over 2 years of age.

Table 1.

 

Age distribution of patients in the experimental group

 

Age

Number of Patients

1 month – 1 year

28 (56%)

1 year – 2 years

14 (28%)

2 years – 3 years

8 (16%)

Total

50 (100%)

 

We determined that typical rates of illnesses occur 1-2 times per year for children of this age range. During the preceeding year, the analysis indicates that the frequency of illness in children ages 0-1 year fell ill less often when compared with the control. For the cohort aged 2-3 years, illness rates remained unchanged. Through the last year, 48% of children fell ill once, and 16% two or more times.

For previous cases of ARVI, therapy consisted of symptomatic treatment: e.g. nasal drops, anti-histamine drugs, immune-modulators and immune-stimulants, cough mixture. In a few cases antibacterial therapy was applied.

Previous case of illness was recorded as follows: one month ago with 17(34%) patients; two months and over ago with 13 (26%) children, and 20 (40%) fell ill for the first time.

 

Table 2.

 

Distribution of patients as per date of last illness

 

Date of previous illness

Number of patients

First time ill

20 (40%)

1 month ago

17 (34%)

2 months and over ago

13 (26%)

 

Half of the patients were observed to have somatic diseases.

 

Table 3.

 

Chronic somatic diseases observed with patients

 

Somatic pathology

Number of patients

Rickets

9 (18%)

Anemia

5 (10%0

Malfunction of alimentary canal

5 (10%)

Atopic dermatitis, allergic reaction

8 916%)

Total

27 (54%)

Symptomatic treatment was given for previous cases of ARVI. Each child was given a combination of drugs, which resulted in costly treatment. The minimal time for recovery was 7 days. Periods of illness in previous cases of ARVI depended on the severity of disease. Treatment regimens consisted of the follow

 

Medicines used in therapy of previous cases of ARVI

Number of patients

Symptomatic (nasal drops)

19 (38%)

Anti-histamines

5 (10%)

Expectorants and Mucolitics

6 (12%)

Antibacterial drugs

6 (12%)

Immune-modulators and Immune-stimulants

8 (16%)

Antipyretics

8 (18%)

 

Analyses of the length of illness prior to admission showed that 23 (46%) of children with ARVI were admitted within 1-2 days from the onset of illness; 27 (54%) of children were admitted on the 3rd day of illness or later. The major complaint for all children was fever, being the major cause for hospitalization of the children, apart from those only a few months old.

 

Analysis of major symptoms is given in the following table:

 

Table 5.

 

Analysis of major symptoms upon admission

 

Major symptoms

Number of patients

Blocked nose

39 (78%)

Running nose

22 (44%)

Difficulties swallowing

5 (10%)

Cough

15 (30%)

Earache

6 (12%)

Cervical adenitis

10 (20%)

Fever

48 (96%)

 

Different rates of device application were tested within the period of one day in order to find an optimal mode for treatment. The “DOCTOR SVET” device was applied from 3-5 times a day.

 

The effect of the device was registered as satisfactory for all children. No negative reactions were observed in any of the tests. The nipple effected a positive attraction for 27 (54%) children, especially those above 1 year. It was accepted by 17 (34%) of the children, while 4 (8%) of the children were indifferent to it, and 2 (4%) spat it out.

 

There was no observation of any allergic reactions.

 

In all cases, symptomatic improvement was observed. The dynamics of the analyzed symptoms (given per day of treatment) are shown in the following tables:

 

Table 6.

 

Dynamics of symptoms with application of the device 3 times per day.

 

Symptoms

Days of

observation

Number of patients (n=5)

2

3

4

5

Catarrh improvement

2 (13%)

9 (60%)

4 (26.6%)

 

Cough improvement

 

4 (26.6%)

2 (13%)

 

Increase of appetite

3 (20%)

10 (67%)

3 (20%)

 

Suckling improvement

3 (20%)

3 (20%)

1 (6.6%)

 

Normalization of general condition

 

9 (60%)

1 (6.6%)

 

 

With an application regimen of 3 times per diem, positive improvements of the analyzed symptoms were observed within 3-4 days from the induction of treatment.

 

Table 7

 

Dynamics of symptoms with application of the device 4 times per day.

 

Symptoms

Days of

observation

Number of patients (n=5)

2

3

4

5

Catarrh improvement

16 (80%)

4 (20%)

 

 

Cough improvement

2 (10%)

4 (20%)

1 (5%)

 

Increase of appetite

10 (50%)

10 (50%)

 

 

Suckling improvement

6 (30%)

2 (10%)

 

 

Normalization of general condition

6 (30%)

14 (70%)

1 (5%)

1 (5%)

 

With an application of the device four times per diem, improvements within analyzed symptoms were observed within 2-3 days from the start of treatment.

 

With an application of the device five times per diem, improvements within the analyzed symptoms were observed within 2-3 days from the start of treatment, and showed no difference from that of the regimen of 4 applications per diem. Thus, application of the device 4 times per day allows for maximum efficiency.

Table 8

 

Dynamics of symptoms with application of the device 5 times per day.

 

Symptoms

Days of

observation

Number of patients (n=5)

2

3

4

5

Catarrh improvement

10 (66.6%)

5 (33.3%)

 

 

Cough improvement

1 (6.6%)

3 (20%)

1 (6.6%)

 

Increase in appetite

7 (46.6%)

7 (46.6%)

1 (6.6%)

 

Suckling improvement

4 (26.6%)

 

 

 

Normalization of general condition

5 (33.3%)

7 (46.6%)

3 (10%)

 

 

In the control group, symptomatic recovery rates were markedly slower.

 

The control group consisted of patients (n=10) ages 3 months to 3 years. All patients had affirmative symptoms of ARVI. In the therapy regimen of these children, different methods of symptomatic therapy were applied: boric-adrenaline nasal drops, protagol drops, suprastin, antipyretics, and, when necessary, with antibacterial drugs.

 

Catarrh improvement was observed on the 4th day of treatment within 3 (30%) of the children. Symptomatic improvements of this symptom for 9 (90%) children were not observed until the 6th day of treatment. By the conclusion of the study, 1 child still expressed symptoms of catarrh.

 

An easing of cough and increase in appetite were observed only by the 4th -5th day from the induction of treatment.

 

A normalization in general health was not observed until the 4th – 5th day from initiation of treatment.

 

Table 9

 

Dynamics of symptoms of the control group.

 

Symptoms

Days of

observation

Number of patients (n=5)

2

3

4

5

6

Catarrh improvement

 

 

3 (30%)

4 (40%)

 

Cough improvement

 

 

2 (20%)

3 (30%)

4 (40%)

Increase in appetite

 

 

4 (40%)

5 (50%)

1 (10%)

Suckling improvement

 

 

4 (40%)

 

 

Normalization of general condition

 

 

4 (40%)

5 (50%)

1 (10%)

 

Based on the given experiment, the following conclusions have been drawn:

 

  1. The clinical efficiency for the use of the “DOCTOR SVET” device in treating infant cases of ARVI has been sufficiently proven.

  2. The optimal and effective mode of application of the “DOCTOR SVET” device is 4 times per day.

  3. With the application of the “DOCTOR SVET” device 4 times a day, symptomatic improvements were observed: on the second day of treatment, there was a marked easing of rhinitis in 16 (80%) of patients, an increase in appetite for 10 (50%) patients, and a normalization in general health within 2-3 days from therapy initiation.

  4. Symptoms of ARVI in patients with background conditions expressed faster recovery rates and an easing of symptoms with the application of “DOCTOR SVET”; with no difference from the improvement rates of children without any previous background conditions.

  5. Patient recovery and symptom easement in patients on whom “DOCTOR SVET” was not applied was markedly slower, and not observed earlier than 4-5 day from initiation of treatment.

  6. Introduction of antibacterial drugs into therapy did not have a significant effect on recovery.

  7. The device did not provoke visible negative reactions from the children and was convenient in application. There were no cases registered of allergic reactions or discomfort.

 

FORM

 

Name in full __________________________________________________

Age _________________________________________________________

Number of illnesses experienced by the child within the last year ____________________

Cases of ARVI _______________________________________________________

Date of last illness ____________________________________________

 

Does the child suffer from any chronic diseases (circle or underline) – rickets, anemia, malfunction of digestive tract (pain, inconsistent stool, vomiting), exudative-catarrhal diathesis, acne, allergic reaction.

 

Treatment given during previous cases of ARVI _____________________________________________________________

_____________________________________________________________

_____________________________________________________________

_____________________________________________________________

 

Date of illness onset: __________________________

 

Major symptoms of disease (circle or underline) – blocked nose, running nose, difficulty swallowing, cough, earache, cervical adenitis, fever.

 

Application of “Nipple”: 3, 4, 5 times per day (underline)

 

Reaction of child (circle or underline) – showed large interest, no interest, normal interest, tried to spit out, cried each time, appearance of painful spots in mouth, allergic reaction ___________________________________

(indicate which reactions observed in your child)

 

Treatment results and observations:

 

IMPROVEMENT, WORSENING of condition (circle)

Rhinitis started to decrease on _________ day of treatment

Cough decreased on _________ day of treatment.

General condition normalized on _________ day of treatment.

Increase in appetite on _________ day of treatment.

Suckling improvement on _________ day of treatment.

Appendix 2

RECORDS

Clinical experiments conducted on the portable physiotherapeutic light-emitting diode device “Doctor Svet” for the treatment of ARVI in infants aged 0-3 years

 

Goal

 

  1. To determine the clinical efficiency of device application in treatment of light and moderate forms of infant ARVI.

  2. To determine the effective method of device application – period of treatment course, frequency of applications per day, starting time of treatment.

  3. To formulate clinical instructions regarding the application of the device, including methods of use, indications, and possible contra-indications.

 

This device is presented for clinical testing; therefore in-clinic tests will not require laboratory procedures for the confirmation of efficacy.

 

STRUCTURE OF STUDY

 

In each clinic 2 groups of patients will be formed by random selection, with 50 children in experimental group and 30 in control group. Groups shall be representative of age, seriousness of illness, and frequency of previous diseases.

 

Criteria for selection of groups shall be:

  • infants from 1 month to 3 years of age;

  • illness characterized by rhinitis, hyperemia of throat, presence or absence of fever.

 

In selection, the following factors shall not be considered: frequency of previous occurrences of ARVI, type of feeding, presence of exudative-catarrhal diathesis, anemia and malfunction of the digestive tract. All these shall be considered background conditions in the final analysis.

 

If a child is selected into the main group, his/her parents are issued with the device and instructions on use. However, it is the responsibility of the experimenter to verbally explain how to properly use the device. Initial application of the device shall be conducted by the parents in the presence of the trained experimenter. Each parent is given a standardized consent form, to be correctly and accurately completed by the parent. The experimenter must explain all points in detail.

 

After 7 days, parents shall return the devices and the completed forms.

 

A final diagnosis is reached based on the given observations and recorded information.

 

It is advisable to select for treatment cases of light and moderate forms at the onset of illness, with the appearance of initial symptoms. No other remedies, apart from antipyretics for temperatures over 38.5 degrees Celsius. should be given. If patient’s condition worsens and it becomes necessary to administer other medications, this must be recorded in the form.

 

 

 

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