(OR11) THE STUDY OF BIO-NORMALIZER (BN) CLINICAL EFFICACY AND IMMUNOMODULATING ACTIVITY IN THE TREATMENT OF INSULINDEPENDENT DIABETES MELLITUS

Title  THE STUDY OF BIO-NORMALIZER (BN) CLINICAL EFFICACY AND IMMUNOMODULATING ACTIVITY IN THE TREATMENT OF INSULINDEPENDENT DIABETES MELLITUS
Year
Author  Michail I. Balabolkin, Ludmila G. Korkina, Ashot M. Mkrtumyan
Publisher

 

R4

The study of Bio-normalizer (BN) clinical efficacy, free radical- and immunomodulating activity in the treatment of insulin-dependent diabetes mellitus 

Korkina LG, et. al

 


 

 TRIAL PROTOCOL

(Confidential)

Pilot Clinical Trial (Phase II)

 

Title: THE STUDY OF BIO-NORMALIZER (BN) CLINICAL EFFICACY AND IMMUNOMODULATING ACTIVITY IN THE TREATMENT OF INSULINDEPENDENT DIABETES MELLITUS

 

Professor Michail I. Balabolkin
Director, Institute of Diabetes

Professor Ludmila G. Korkina, M.D., Ph.D., Dr.Sci.
Research Supervisor

Dr. Ashot M. Mkrtumyan, M.D.
Clinical Investigator. 

 

 

 

Table 1 The effect of BN administration on monocyte luminol amplified chemiluminescence

N Spont
2nd
visit
Spont
3rd
visit
PMA -activ.
2nd
visit
PMA-active
3rd
visit
PMA+
NAME
2nd
visit
PMA+
NAME
3rd
visit
Zym-activ.
2nd
visit
Zym-activ.
3rd
visit
Zym+
NAME
2nd
visit
Zym+
NAME
3RD
visit
1 9 261 54 384 9 223 8 4240 8 2650
2 27 130 157 103 36 449 73 303 72 265
3 74 578 1024 625 354 308 803 2820 715 1914
4 60 687 572 463 380 272 590 5192 425 4143
5 83 n.a.* 154 n.a.* 57 n.a.* 113 n.a.* 118 n.a.*
6 34 48 30 356 14 146 10 1616 8 952
7 232 75 876 262 72 117 310 2522 165 1230
8 62 51 870 301 187 232 4 1286 3 1005
9 10 392 8 497 5 275 5 4424 2 1825
10 18 197 8 5520 3 1800 0 4100 0 2538
11 21 51 35 301 18 18 27 1188 20 706
12 31 60 51 382 15 179 5 2588 2 1516
13 93 288 540 559 301 326 1729 7254 1388 2866
14 180 200 963 1068 303 652 1468 4518 923 1965
15 500 394 1483 894 720 421 2767 4780 1640 2529

 

 

Table 2 Effect of BN administration on monocyte lucigenin-amplified CL

N Spont
2nd visit
Spont
3d visit
PMA-activ.
2nd visit
PMA-activ.
3rd visit
Zym-activ.
2nd visit
Zym-activ.
3rd visit
1 1 2 9 40 5 120
2 4 3 21 52 18 312
3 11 7 119 193 103 1591
4 8 25 59 195 56 2320
5 4 n.a.* 35 n.a.* 14 n.a.*
6 2 6 10 48 2 238
7 4 8 41 42 37 342
8 5 35 15 466 70 3800
9 4 9 9 48 4 504
10 3 19 11 180 4 251
11 4 12 19 96 10 160
12 4 14 12 48 8 260
13 20 16 84 75 355 570
14 8 7 48 46 214 433
15 8 11 106 95 511 447

 

 

Table 3 The effect of BN administration on neutrophil lumino;-amplified CL

N Spont
2nd visit
Spont
3d visit
PMA-activ.
2nd visit
PMA-activ.
3rd visit
Zym-activ.
2nd visit
Zym-activ.
3rd visit
1 7 512 14 630 0 8760
2 5 2010 20 1766 23 7921
3 14 1407 418 1474 170 9345
4 12 1235 89 1081 220 12300
5 340 n.a.* 320 n.a.* 468 n.a.*
6 140 198 113 200 60 2540
7 84 501 150 785 2522 15054
8 85 2110 512 2280 25 28932
9 45 1094 216 2475 27 13709
10 134 932 465 1955 119 26411
11 122 618 491 1489 35 25585
12 320 608 51 1849 90 26144
13 771 796 2748 7615 10531 23739
14 416 797 8315 8731 19486 16523
15 675 38 5163 119 13340 214

 

 

Table  4 Effect of BN administration on neutrophils lcigeni-amplified CL

N Spont
2nd visit
Spont
3d visit
PMA-activ.
2nd visit
PMA-activ.
3rd visit
Zym-activ.
2nd visit
Zym-activ.
3rd visit
1 10 43 35 400 18 1900
2 8 205 22 418 24 2618
3 5 63 13 169 27 2587
4 2 71 18 171 48 3228
5 52 n.a.* 12 n.a.* 25 n.a.*
6 25 7 8 55 13 424
7 17 3 20 143 17 1673
8 15 35 26 466 140 3800
9 10 34 27 148 24 1847
10 22 50 78 486 7 2357
11 18 47 110 167 9 1966
12 30 43 72 151 30 2259
13 88 56 197 373 1702 2963
14 74 26 309 454 1536 1655
15 25 8 185 63 2240 74

 

 

Table 5 Effect of BN administration on the contest of SOD and catalase in the whole blood and leukocytes

N SOD in the whole blood µg/mg protein Catalase in the blood µg/g Hb Leukocyte
CuZnSOD
Leukocyte
MnSOD
Ng/mg protein
2nd visit 3d visit 2nd visit 3d visit 2nd visit 3d visit 2nd visit 3d visit
1 45 56 25 17 474 70 380 327
2 56 50 27 26 117 177 584 76
3 43 23 38 27 64 63 569 80
4 36 58 26 19 95 102 171 69
5 50 n.a* 30 n.a* 159 n.a* 45 n.a*
6 46 47 29 21 343 82 115 172
7 50 40 24 27 0 184 220 106
8 43 48 29 18 552 98 46 82
9 70 85 29 33 185 232 228 274
10 95 80 22 21 327 77 104 248
11 108 135 28 24 167 0 304 160
12 61 128 30 26 418 890 340 521
13 62 92 27 23 35 29 293 372
14 53 90 24 28 116 475 205 158
15 54 86 23 31 45 193 182 111

 

Table 6 Effect of BN administration on lymphocyte subpopulation (%)

N CD3+ CD5+ CD4+ CD8+ CD14+ CD4+/CD8+
2nd
visit
3d
visit
2nd visit 3d
visit
2nd visit 3d visit 2nd visit 3d
visit
2nd visit 3d visit 2nd visit 3d
visit
1 67.8 58.5 55.6 50.6 40.8 45.6 17. 28.0 2.6 6.4 1.46 1.63
2 71.4 58.4 54.8 60.0 36.2 18.9 28.3 11.1 5.6 14.2 1.28 1.70
3 62.6 61.4 62.2 61.0 45.2 42.1 27.9 14.3 6.5 11.0 1.62 2.94
4 32.5 71.7 41.9 70.0 43.0 42.9 27.4 27.1 7.6 22.2 1.57 1.58
5 10.0 n.a* 41.9 n.a* 18.4 n.a* 14.2 n.a* 7.0 n.a* 1.30
6 40.5 62.9 52.8 54.5 33.4 42.6 17.0 18.6 7.7 12.3 1.96 2.29
7 67.5 67.8 45.6 50.4 42.6 34.7 28.6 33.2 7.3 10.2 1.50 1.05
8 74.0 66.4 63.5 62.4 42.6 15.3 29.0 16.1 10.9 12.0 1.47 0.95
9 22.9 72.5 21.9 66.4 20.4 41.6 22.1 18.9 4.1 5.8 0.92 2.20
10 61.3 53.5 63.3 46.2 31.5 28.2 29.2 40.8 12.2 4.7 1.08 0.69
11 60.5 52.0 55.5 49.0 32.2 40.1 18.5 33.7 1.3 10.8 1.74 1.19
12 56.8 57.0 62.7 60.0 26.0 30.0 35.7 34.0 11.5 9.0 0.73 0.88
13 71.3 80.6 54.0 73.0 49.9 58.8 21.9 18.6 4.5 3.7 2.28 3.16
14 76.3 68.3 70.3 66.0 48.9 48.0 25.3 22.1 9.6 4.3 1.93 2.17
15 52.6 60.2 54.9 56.7 26.8 47.9 15.5 12.0 7.7 4.3 1.73 3.49

 

 

Table 7 Effect of BN administration on lymphocyte and monocyte subpopulations

N 3F3 NK CD14+lymphocytes CD14+ monocytes
2nd visit 3d visit 2nd visit 3d visit 2nd visit 3d visit 2nd visit 3d visit
1 19.0 11.0 25.8 19.5 2.6 6.4 72.4 47.4
2 17.3 10.6 18.3 15.5 5.6 14.2 72.3 56.0
3 11.4 8.4 2.4 20.8 6.5 11.0 65.4 61.2
4 18.7 26.0 25.6 21.8 7.6 22.2 46.2 63.5
5 34.4 n.a* 8.9 n.a* 7.0 n.a* 45.9 n.a*
6 23.9 12.7 32.4 27.2 7.7 12.3 55.8 84.3
7 12.1 10.3 13.6 20.8 7.3 10.2 65.9 80.2
8 10.1 7.4 22.0 9.2 10.9 12.0 60.2 83.6
9 17.5 23.5 14.3 14.3 4.1 5.8 13.3 76.1
10 17.5 9.5 18.6 21.0 12.2 4.7 43.9 25.6
11 14.2 10.0 10.4 17.7 1.3 10.8 37.6 60.1
12 13.8 11.0 20.4 19.0 11.5 9.0 48.1 60.0
13 8.1 8.6 24.4 10.3 4.5 3.7 66.0 78.6
14 11.7 25.9 21.0 20.7 9.6 4.3 84.3 77.4
15 14.7 14.2 18.4 8.6 7.7 4.3 61.3 85.6

 

Table 8 Effect of BN administration on the contents of immunoglobulins

N

IgG (G/L)

IgA (g/L)

IgM (g/L)

2nd visit 3d visit 2nd visit 3d visit 2nd visit 3d visit
1 12.0 11.5 1.05 1.20 1.45 1.90
2 7.6 5.8 1.0 0.97 1.27 1.13
3 6.9 6.0 2.6 2.1 1.60 1.32
4 14.5 14.0 1.8 1.8 2.4 2.4
5 10.0 n.a* 3.0 n.a* 3.8 n.a*
6 14.5 13.3 2.6 2.6 1.7 1.7
7 8.2 8.3 3.2 3.0 1.2 1.3
8 014.0 15.5 1.9 1.9 2.4 2.6
9 14.5 12.0 3.8 3.6 1.8 1.6
10 19.5 17.0 2.6 2.3 2.4 2.1
11 14.5 14.5 3.6 3.3 2.3 2.3
12 11.0 10.5 1.5 1.4 1.9 1.5
13 9.0 8.6 2.9 2.6 1.2 1.3
14 8.6 7.9 2.0 1.9 1.2 1.3
15 5.6 7.9 1.2 1.9 1.1 1.3

 

 

 

 

 

 

 

Table 9 Diabetes mellitus market in the blood.

Number

Glucose content
(mmol/L)

Glycosylated
Hemoglobin (%)

Keton content
(mmnol/L)

Before BN After BN Before BN After BN Before BN After BN
1 8.4 6.2 9.2 8.4 0 0
2 6.6 10.4 11.6 9.2 0 0
3 5.3 5.1 10.8 8.1 0 0
4 5.6 4.6 10.2 9.1 0 0
5 14.5 n.a* 9.9 n.a* 9 n.a*
6 8.4 6.6 10.9 10.4 0 0
7 7.8 6.8 11.3 9.6 0 0
8 7.3 5.5 12.2 9.8 5.4 3.2
9 5.8 5.6 5.2 4.8 0 0
10 7.8 7.4 9.4 10.5 0 0
11 8.8 7.6 13.4 13.2 8 6
12 6.6 5.0 10.2 9.8 0 0
13 8.2 7.6 9.8 9.7 2.5 1.0
14 6.0 5.8 9.0 9.1 0 0
15 7.8 4.6 14.0 10.2 0 0

 

 

Table 10  Diabetes mellitus market in the urine.

Number

Glucose content
(g/L)

Microalbumin
(mg/L)

Urine output a day
(L)

Before BN After BN Before BN After BN Before BN After BN
1 0 0 180 160 2100 1600
2 23 8 340 300 1800 1500
3 30 19 0 0 2600 1900
4 15 0 0 0 2600 1900
5 88 n.a* 250 n.a* 4000 n.a*
6 28 15 200 156 2200 1850
7 39 17.5 150 120 2000 1600
8 36 6 95 60 2500 2200
9 0 0 0 0 1350 1250
10 36 24 350 360 2500 2200
11 70 50 n.a* n.a* 2100 1500
12 29.5 22.2 0 0 2100 1800
13 31 21 150 130 2500 2200
14 20 22 0 0 1670 1700
15 42 12.5 0 0 2350 2000

 

 

Table 11. Clinical symptoms of diabetis mellitus.

Number Insulin requirement
(U/day)
Liver enlargement
(cm below costal line)
Pancreas disorders
Before BN After BN Before BN After BN Before BN After BN
1 0 0 0 0 - -
2 44 28 2.0 1.5 + -
3 28 28 2.5 0 - -
4 42 36 0 0 + -
5 32 n.a* 0 n.a* - n.a*
6 28 24 1.0 0 - -
7 36 30 3.0 0 - -
8 32 28 1.5 0 - -
9 28 28 0 0 - -
10 42 40 1.0 1.0 - -
11 40 36 1.0 1.0 - -
12 30 28 0 0 - -
13 32 32 0 0 - -
14 32 24 0 0 - -
15 26 20 0 0 - -