Approved by

The Pro-rector for Research of State Educational Institution of Higher Professional Education
Bashkir State edicine !niversity of the "ederal Agency for Health #are and Social $evelop%ent
$octor of edicine& Professor
(Signature) E'(' Alekhin
)ove%ber *+& ,--.
(Seal: State Educational Institution of Higher Professional Education
Bashkir State Medicine University of the Federal gency for Health !are and Social "evelo#$ent)
Minutes
of Clinical Tests to Study
the Efficiency of Treatment Applying DETA-AP-13 device
!!"
#esearch $asis%
Post-Approval #linical Testing Agree%ent dated arch ,/& ,--.'
Test aim% To assess the opportunities to apply $ETA-AP-*0 device %anufactured by 111 E2IS
Research and $evelop%ent Enterprise in %edical practice on the territory of the Russian "ederation in case
of gastric ulcer and duodenal ulcer 3during partial re%ission4'
Type of testing% open& non-rando%& co%parative'
Test tas&%
*' to deter%ine the clinical efficiency of $ETA-AP-*0 in case of gastric ulcer and duodenal ulcer as the
sole therapy'
,' to study the clinical efficiency of $ETA-AP-*0 application in case of gastric ulcer and duodenal ulcer'
0' to assess the safety of $ETA-AP-*0 application in case of gastric ulcer and duodenal ulcer 3during partial
re%ission4 as the sole therapy'
Plan of testing% clinical testing is conducted 5ith ,, patients' Patient 5ere selected in accordance 5ith the
specified inclusion criteria'
'nclusion criteria% T5enty t5o persons 5ith laboratory serological tests through i%%une and en6y%e
analysis of titre of specific antibodies to antigens of Helicobacter pylori participated in the testing' Tests and
treat%ent 5ere carried out on the basis of infor%ed voluntary consent of the patient according to the 1rder )o' *70
3Industry-specific Standard 31ST4 .*+--'*8'---*-,--,4 of the inistry of Health of the Russian "ederation'
Time and place of the tests% in a clinic& at ho%e'
#epresented for the tests%
*' $ETA-AP-*0 device %anufactured by 111 E2IS Research and $evelop%ent Enterprise 3osco54& * ite%9
soft5are of the device provides antiparasitic therapy'
,' $ETA-AP-*0 device is authori6ed for application in %edicical practice 3Registration certificate of the "ederal
Service on Surveillance in Healthcare and Social $evelop%ent of Russian "ederation )o' "SR ,--.:-+78* dated
September 04, 20094'
0' $ETA-AP-*0 anual'
8' ethodological reco%%endations for application of $ETA-AP-*0' $iagnosis and treat%ent %ethods are
covered by patents )o' ,---**8+;/ dated arch ,-& ,--0& used by 111 E2IS Research and $evelop%ent
Enterprise on the legal basis'
Test results%
The research of clinical efficiency of different 5ays to treat gastric ulcer and duodenal ulcer 3during
partial re%ission4 5as carried out a%ong ,, patients 3, %en& *7 5o%en being fro% ,- to 7- years old and 8
children fro% *, to *+ years old4' <astric ulcer and duodenal ulcer 5ere diagnosed clinically and evidenced
by the data of i%%unological studies and functional diagnosis of gastrointestinal tract organs applying
electroacupuncture'
The control group 3drug therapy only4 consisted of *, persons 3+ %en and + 5o%en being fro% ,+ to ++
years old and , children being fro% *- to *, years old4'
The study groups 5ere of si%ilar se=& age& nosological entities& severity of the underlying disease and
intensity of clinical i%plications of gastric ulcer and duodenal ulcer 3during partial re%ission4' 1nly patients
having gastric ulcer and duodenal ulcer during partial re%ission participated in the testing'
Treatment method( $ETA-AP-*0 device 5as prepared to the treat%ent in accordance 5ith the $ETA-AP-*0
$evice anual' The device 5as s5itched on and off in accordance 5ith the instructions of the anual' $uring the
session the device 5as located 5ithin a radius of ,--0- c% fro% epigastric area' The session duration is
,78- seconds& one session a day& the course takes fro% + to 7 days'
The efficiency of different treat%ent %ethods for gastric ulcer and duodenal ulcer is assessed through
daily clinical e=a%inations& including assess%ent of the general state of health& condition of skin& functions of
the gastrointestinal tract 3appetite& dyspepsia& abdo%inal pains& belching4' #oncerning laboratory
e=a%inations specific antibodies to antigens of Helicobacter pylori 5ere deter%ined through i%%une and
en6y%e analysis' #oncerning e=a%inations %ethods applying %edical e>uip%ent electric potential of points
SPE$ 0-de=& I< -8 de= ? sin& TR-+-de=& I< -8 -de=& I< -8 @sin 5as %easured'
#linical %onitoring of patients treated by the device as the sole therapy of gastric ulcer and duodenal
ulcer and co%bined treat%ent& including prebiotics& natural enterosorbent and antibiotics revealed a %ore
pronounced positive effect co%paring to the control group e=pressed as reduction of gastrointestinal
dyspepsia& increased functional activity of gastrointestinal tract organs& deter%ined by electroacupuncture
diagnosis %ethod& and reduction of titre of specific antibodies applying i%%une and en6y%e analysis'
Table *'
$yna%ics of the %aAor clinical sy%pto%s& i%%unological para%eters and indicators of gastrointestinal
tract activity& deter%ined by electroacupuncture diagnosis %ethod a%ong the patients having gastric ulcer
and duodenal ulcer 3during partial re%ission4'
<roups of patients having la%bliosis
Sy%pto%s
The *
st
group $ETA-AP-*0
device )B**
The ,
nd
group $ETA-AP-*0
device C drug co%ple= )B**
The 0
rd
group
drug co%ple= )B*-
)u%ber of patients D )u%ber of
patients
D )u%ber
of
patients
D
Paleness Before--- . /, *- .* *7 /-
of skin treat%ent
After
treat%ent
0 ,; , */ / 8-
Asthenic
syndro%e
Before
treat%ent
/ ;0 ; 78
After
treat%ent
0 ,; *
.
Abdo%inal
pains
Before
treat%ent
*- .* *- .* *7 /-
After
treat%ent
, */ - - ; 0+
EIA high tite of
specific
antibodies
according to
Ig<
Before
treat%ent
/ ;+ . /, . .-
After
treat%ent
, */ * . 0 0-
After 0
%onths
Three patients have 6ero& eight
patients have less than 0 %onths
period after the treat%ent
- "ive patients
have 6ero& si=
patients have
less than 0
%onths period
after the
treat%ent
- 8 8-
Electroacupuncture diagnosis 3average indices4
TR-+-de= Before
treat%ent
,+-0- ,+-0+ ,+-0+
After
treat%ent
0+-8+ 0+-+- ,+-8-
SPE$ 0-de= Before
treat%ent
*--,+ *0-,; *0-,/
After
treat%ent
0--8- 0+-+- 0+-8-
I< -8-de= Before
treat%ent
;-*+ /-*; *--,+
After
treat%ent
0--8+ 8--+- ,+-8+
I< -8 -sin Before
treat%ent
;-*+ /-,- ,+-8-
After
treat%ent
0+-8- 0+-+- ,+-0-
Tolerance' It should be noted that $ETA-AP-*0 is 5ell-tolerated& there is no general and local adverse
reactions The therapy did not have negative i%pact on the conco%itant pathology of patients'
Conclusion(
*' $ETA-AP-*0 device regarding its functional and application features fully co%plied 5ith the
re>uire%ents of %edical practice in treating gastric ulcer and duodenal ulcer'
,' Pronounced clinical efficiency of $ETA-AP-*0 device is detected as the sole therapy and in
co%bination 5ith drug therapy co%paring to traditional treat%ent %ethods'
0' There is no contraindication to the use of $ETA-AP-*0 device a%ong the patients having la%bliosis
of intestinal tract'
8' $ETA-AP-*0 device %ay be used during the hospital and out-patient treat%ent and at ho%e'
#ecommendations(
1n the basis of the above stated facts& on the clinical tests& 5e propose to add the device to the regional
standard e>uip%ent for outpatient institutions and clinics& as 5ell as hospitals 3%ini%u% re>uire%ents
therefore are deter%ined by 1rder of the inistry of Health #are and Social $evelop%ent of the Russian
"ederation )o' ;+0 dated $ece%ber -*& ,--+4 for the follo5ing specialistsE
*4 <eneral Practitioner'
,4 <astroenterologist'
04 Pediatrician'
In this case $ETA-AP-*0 devices %ay be purchased on budgetary funds& or at the e=pense of patients
for personal use'
The said reco%%endation 5ill be legiti%ate according to an order of an authority regulating health care in
the region and 5ill have positive i%pact on the i%prove%ent of %edical services for people'
E=ecutive in chargeE #andidate of edicine&
$octor-laboratory assistant of the highest class
Antonina "ridrikhovna Iskhakova
(Signature)
Scientific Supervisor:
#hair of Subdepart%ent of 2abour Hygiene and
Professional $iseases& $octor of edicine&
Professor
Fakiya Sagadatovna Teregulova
(Signature)