Prostanal now pass registration at the Pharmacological Committee of the Ministry of

Health and Social Affairs of Georgia.

Prostanal has passed preclinical and clinical trials in following organizations:

 

• JSC National Center of Urology, Tbilisi, Georgia.

• Clinical and Experimental Research Institute of Tbilisi State Medical University;

• Medical & Biological Scientific Research Centre  – Company <<Alexis>>;

• Laboratory of Cell Signal Mechanisms of the I.Paladin Institute of Biochemistry at

• Ukrainian Medical Academy;

• Medical Research Institute of Physical Chemistry at the Ministry of Healthcare  of

• Russian Federation;

• Pharmacological Department of the Medical University of Russian Federation;

• Fuji Memorial Institute of the Preclinical Research, Bivako/Japan;

• Tokushima Otsuka Immunology Research Institute, Japan;

• Tokushima Institute  of New Drug Research and Safety Evaluation, Japan;

 

Prostanal is recommended for the treatment of chronic banal prostatitis.

 

Prostanal is a standardized combination of peptides identified from ecologically pure raw materials of plant origin (Know-how), by biochemical and chromatographically methods. In medical practice, it is used as a colorless injection solution.

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The clinical trials of Prostanal showed that it is almost safe preparation. Its reception improves the urination process, considerably reduces the dysuric phenomena and has a positive impact on the improvement of quality of life. In a number of patients preparation reception also improves ejaculation. The specified influence is possible to explain by the impact of a preparation on the developments of stagnation, caused in prostate iron a syndrome of congestion of a hip and a positive influence on inflammatory processes. The clinical studying of Prostanal and demand carrying out further deeper research, and on the basis of results of the research carried out by us we already can judge an essential contribution in prostatitis treatment. Together with the obtained data of the clinical research, the fact established by preclinical researches the strong immunotropny influence of Prostanal and on the immune system of an organism is considerable. In particular, it possesses ability of activation of macrophages, neutrophils, and cytotoxic cells. It is known that these links of immunity are responsible for the antimicrobic activity, for phagocytosis the infected and damaged cells, for use as the construction material of a number of products of disintegration in an organism and/or their elimination from an organism. As it is known from prostatitis etiology, one of the important factors of an origin and development of this disease are inflammatory processes caused by microbes.

 

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JSC National Urology

Center named after Tsulukidze Ave

Tbilisi 0144, No. 9 Tsinandali St.

tel. 227 35 31 Fax: 277 44 95

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№ 02/608

30.12.2009 

Director of the research direction

 "National Urological Center

Named after Al. Tsulukidze" doctor of medical sciences,

professor, coordinator of clinical research

Giorgi Bochorishvili

 

 

Clinical trials on patients with prostatitis

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PROSTANAL represents the standardized complex of peptides with immunomodulatory properties. Therefore, antimicrobic properties PROSTANAL, caused by the above-stated immunotropic action, also can make a significant contribution in the treatment of prostatitis.

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Except for the above-named properties, PROSTANAL possesses sharply expressed antioxidant action that is very essential to the neutralization of free radicals damaging an organism and an organism detoxication. This property of PROSTANAL undoubtedly has a considerable impact on the processes of treatment of prostatitis. It is known that one of the harmful symptoms characterizing prostatitis is the general intoxication.

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Proceeding from the results of carried out research and following from concrete immunotropic properties of preparation, the preparation PROSTANAL can be recommended in clinical medicine, as a safe and effective remedy of treatment of prostatitis.

It is known that peptides, as small molecules, are easily transported between tissues and at the same time possess ligand tropism, i.e. specific interaction with membrane receptors. Here it should be noted that this very small size active peptides act in the very small – nano - and pico-concentration.

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Preliminary clinical researches were conducted on patients with prostatitis, the patients volunteer in a clinic No. 1 of skin and venereal diseases of Tbilisi of the Ministry of Healthcare, labor and social protection of Georgia. 36 patients had a diagnosis of Trichomonas prostatitis, and chronic- banal prostatitis – at 38 patients. As a result of the conducted researches it was revealed that action of the immunotherapeutic preparation PROSTANAL causes in blood recovery of quantitative and functional characteristics of immune systems of В and T cells, in particular, T-helpers, T-cytotoxic cells, T-killers (NK cells), macrophages, neutrophils, granulocytes; causes normalization of ratio T-helper and T-suppressor cells, induction of production of cytokines, including factors of a necrosis of a tumor (TNF-α), gamma interferon, etc.; The preparation restores functional activity of stem hemopoietic cells; normalizes in blood levels of leukocytes, erythrocytes, uniform elements, ERS, also organism temperature. The preparation    PROSTANAL also positively influences the composition of sodium, potassium and other mineral substances in the blood, which has sharply expressed antioxidant activity and ability to eliminate heavy metals from an organism.

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The assessment of preclinical safety which was carried out in compliance with existing requirements and occurred the corresponding pathomorphological, biochemical and hematologic methods on experimental animals, did not reveal any essential difference in comparison with a control group that points to lack of toxic influence of the preparation PROSTANAL in studied doses.

Proceeding from the stated properties and for efficiency and safety of PROSTANAL assessment, in the National urological center, the first phase of clinical researches was carried out. For this purpose in the policlinic of the urological center as a result of data collection of the anamnesis and carrying out researches randomized (every third) patients of experimental and control groups were selected.

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To patients of the 1st group, the nurses of the center daily injected the preparation     PROSTANAL. The course of research was estimated daily by the attending physician and the coordinator of the research.

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Preparation (0,02% solution) was injected intramuscularly once per 24 hours taking into account the weight of the patient.

During the initial visit at each patient, the out-patient card was open and the anamnesis was collected.

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All the patients were treated:

• digital rectal survey (DRS) massage of the prostate and collecting a secret of a prostate (prior to treatment and after its termination);

• the general analysis of urine after massage (prior to treatment and after its termination);

• bacteriological research of urine after a massage;

• research of a secret of a prostate (prior to treatment and after its termination);

• ultrasonic inspection of uric system (a kidney, a bladder, prostata+ostatochny urine) (prior to treatment and after its termination);

• research of a specific prostate-anti-gene;

• determination of C reactive protein (prior to treatment and after its termination);

• the patient filled in the questionnaire on the sum of the international symptoms of prostate and quality of life (prior to treatment and after its termination).

 

Carrying out the specified researches and the analysis of data carried out by the coordinator of research together with the attending physician. After confirmation of anamnesis, the patient was informed on the treatment with PROSTANAL  and offered participation in research. All informed patients were included in the experimental group, after acquaintance with instruction on a consent sheet confirmed with the signature the consent to inclusion in research.

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After receiving consent from the patients, the research group was instructed about an order of reception of medicine which meant its daily injection. The preparation was constantly stored in the refrigerator at a temperature + 40C.

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Each thirtieth day after the reception of PROSTANALthe meeting with the attending physician was held and reception of a preparation proceeded for 30 more days. For the 90th day after preparation reception to patients was carried out:

• digital rectal survey (DRS) massage of prostate and collecting a secret of a prostate (prior to treatment and after its termination);

• the general analysis of urine after the massage

• research of a secret of a prostate

• ultrasonic inspection of the uric system (kidney, bladder, prostata+ residual urine)

• determination of C reactive protein.

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Criteria of inclusion of patients in research are:

• chronic bacterial prostatitis;

• syndrome of a chronic illness of a hip;

• abacterial prostatitis;

• with poorly expressed irritation syndrome.

 

Criteria of a non-inclusion in research:

• sharp bacterial prostatitis;

• sharp impassability of urine;

• hyperallergic reactions to medicines and food;

• with obstructive syndromes;

• cancer of prostate.

 

The planned number of participants of research

The studied (main) group consisted of 30 patients aged from 27 up to 61 years (average age of 36 years): control group I consisted of 15 patients at the age of 27-62 years (average age of 44 years)

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Number of visits and general duration of treatment:

visits to the attending physician of patients participating in research - 3;

visits to the coordinator of research of patients participating in research – 1;

the general duration of research – 90 days.

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Results of  Research, Main group

Data for bacterial research

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In 11 patients of the main group bacteriological studying of urine after a massage of a prostate recorded the negative growth of a bacterium. In 11 cases I growth of enterokok. From them in 5 cases the grown flora had etiological value. E. coli was established in 4 cases, only in 1 case with an infection of etiological value. In all three cases of a streptococcal infection, it had no etiological value and in one the staphylococcal infection of этиологического value.

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At patients of the main group was established:

• good-quality hypertension with a syndrome of congestion of a hip – 13 patients;

• with bacterial prostatitis and a congestion syndrome – 6 patients;

• with abacterial prostatitis – 11 patients.

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Premature eaculation

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13 patients of the studied group regularly had a premature ejaculation, which was completely normalized right after the termination of a course of treatment at 9 patients, and in 4 cases the condition remained without change.

Accompanying disease 5 patients of the studied group had sugar debit because of which to them carried out medicamentous treatment.

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Sum of international symptoms of the prostate – IPSS

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For an assessment of violation of this or that extent of the process of a urination patients filled a questionnaire, which was based on IPSS analysis – the sums of international symptoms of a prostate which prior to treatment fluctuated from 9 to 19 (on the average 14.7). After treatment, these data significantly decreased – from the 2 up to 12 (on average 6.6) that pointed to the improvement of the process of urination. Within 3 months of the treatment with PROSTANAL, this indicator was reduced twice in comparison with the control group.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Fig. 13. IPSS changes in 3 months

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Quality of life – QOL

Prior to treatment, this indicator fluctuated between 2 and 4 (on the average 2,4). By the end of the treatment, its improvement from 0 to the 2nd (on the average 0,5) also was noted. A significant improvement of compared criteria was noted during their comparison with the same indicators of the control group.

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Prostate volume

Prostate volume in the main group fluctuated between 15 and 51 cm3 (on average 24,4), and after the end of treatment, it rather decreased and fluctuated from 14 to 40 cm3 (on average 21,3).

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Residual urine

In the main group, the volume of residual urine fluctuated from 0 to 90 ml (on average 8,8 ml). After treatment, residual urine was noted only at one patient – 30 ml.

At all patients, except for one, there was noted that after intramuscular injection of preparation had no hypertension reaction, and also complication and difficulties. At one patient after the 3rd injection, the aggravation of former dysuria which he did not connect with other additional factors and therefore from the main group was transferred to the control one.

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Fig. 14. Changes of quality of life of Qol in 3 months.

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Control group

The control group was formed as follows. 12 patients of the same age group, which addressed in 2009 in the polyclinic office of the Center of urology with irritational symptoms of the bottom uric step entered into it. 3 randomized patients refused to be included in the main group and filled the control group. Further, in the control group there was added one more patient from the main group who refused treatment after three injections of postanal and to it, the corresponding treatment was prescribed.

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At two patients from the control group, it was established adenocarcinoma of prostates and one patient long time continued hormonal treatment.

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As a result, control of investigated contingent included data of 14 patients.

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To patients of the control group was carried out the following treatment:

• To 7 patients - an antibacterial therapy+alphablocers+phytotherapy;

• To 4 patients - phytotherapy+ alphablocers;

• To 3 patients - phytotherapy+ alphablocers.

 

Treatment duration in the control group equaled also to 3 months.

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Specific anti-gene of a prostate (SPA)

This indicator was defined only at the initial stage and hesitated between 0,27-15,76, on the average equaled to 5,31.

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С reactive protein CRP

The research was conducted prior to the beginning of and after the end of treatment. The initial indicator of CRP fluctuated between 0,98-26,09, on average equaled to 4,19, and to the treatment end it already fluctuated between 0,33-26,09 and the average value was equal to 4,19.

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Data of bacterial research

Bacteriological research of urine after prostate massage in 2 patients of the control group recorded negative growth. In 3 cases grew энтерокок, but in all cases the grown flora had ethiological value. E. coli was defined in 8 cases, from which in 5 cases with an infection of ethiological value. In 1 case of a streptococcal infection, it had etiological value and in 1 case the staphylococcal infection of ethiological value grew.

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At patients of control group were established:

• good-quality hypertension of a prostate with a syndrome of a congestion of a hip – at 6 patients;

• with bacterial prostatitis and with a congestion syndrome – at 8 patients.

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Premature eaculation

8 patients of control group regularly suffered a premature ejaculation after the termination of a course of treatment was completely normalized only at 2 patients, and in 6 cases the situation remained without change.

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Accompanying disease

2 patients of studied group had a diabetes because of which to them carried out medicamentous treatment and at one patient the gerpesny infection was noted.

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Sum of the international symptoms of a prostate – IPSS

For an assessment of the quality of violation of the process of urination patients of control group filled in the questionnaire which was based on the analysis of the sum of the international symptoms of a prostate – IPSS prior to treatment fluctuated from 12 to 27 (on the average 17,86). After treatment, these indicators decreased and fluctuated between 7 and 22 (on average 13,26).

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Quality of life - QOL

Prior to treatment, this indicator fluctuated between 3 and 4 (on average 3,1). By the end also treatments improvement from 1 to the 3rd (on the average 1,9) was noted.

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Prostate volume

Prostate volume in the main group fluctuated between 12-68 cm3 (on the average 36,6) which after treatment fluctuated between 12-66 cm3 (on the average 35,3).

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Residual urine

In the main group, the volume of residual urine fluctuated between 0-350 ml (on the average 56,3 ml). After treatment the volume of residual urine fluctuated between 0-50 (on average 9,2).

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Conclusion

The clinical studying of PROSTANAL showed that it is almost safe preparation. Its reception improves the urination process, considerably reduces the dysuric phenomena and has a positive impact on the improvement of quality of life. In a number of patients preparation reception also improves eaculation. The specified influence is possible to explain by the impact of a preparation on the developments of stagnation, caused in prostate iron a syndrome of congestion of a hip and a positive influence on inflammatory processes. The clinical studying of PROSTANAL  and demand carrying out further deeper research, and on the basis of results of the research carried out by us we already can judge an essential contribution in prostatitis treatment.

​

Together with the obtained data of the clinical research, the fact established by preclinical researches the strong immunotropny influence of PROSTANAL  and on the immune system of an organism is considerable. In particular, it possesses ability of activation of macrophages, neutrophils and cytotoxic cells. It is known that these links of immunity are responsible for the antimicrobic activity, for phagocytosis the infected and damaged cells, for use as a construction material of a number of products of disintegration in an organism and/or their elimination from an organism. As it is known from prostatitis ethology, one of the important factors of an origin and development of this disease are inflammatory processes caused by microbes.

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