REPORT on the results of clinical study of peptide bioregulator Zhenoluten

Written by KHAVINSON, Ph.D., Vladimir

Translated from Russian

                     “APPROVED BY”

Director of the Medical Center

of Saint Petersburg Institute of Bioregulation and Gerontology, corresponding member of the Academy of Sciences, professor,   

Doctor of Medical Sciences

 

                                                       _________________________V.H. KHAVINSON

 

                                                           «______»___________________2011

 

 

 

 

REPORT

on the results of clinical study

of biologically active food additive

Zhenoluten

  

 

        Saint Petersburg

2011

 

Biologically active food additive Zhenoluten contains a complex of low-molecular peptides with molecular weight up to 5000 Da, isolated from ovarian tissues of young animals – calves up to 12 month of age or pigs.  

            Zhenoluten is manufactured in the form of capsules with active substance content 10 mg.

Experimental studies have shown that peptides have tissue-specific action on the cells of the tissues, which they were isolated from.  Zhenoluten peptides regulate metabolism processes in the ovarian cells, improve their safety margin, have a favorable effect on organism adaptive capabilities in extreme conditions, have antioxidant properties, regulate peroxidation processes in the ovarian tissues. Thus it can be expected that Zhenoluten is efficient for restoration of reproduction system functions at their disorders of various genesis.

Age-related or pathological changes of the ovarian function are characterized by development of complicated symptom complex with signs of neuropsychic, vasomotor and metabolic-endocrine disorders, united in a concept of “climacteric syndrome” (1, 4, 5). These disorders take place in the woman organism at the age over 45, they considerably decrease their quality of life.

            Now the tratment of clinacteric syndrome and exhausted ovary syndrome is based on pharmaceutical non-hormonal and hormonal preparations, many of them have serious contraindications and side effects (2, 3):

  • sympatholytics – reserpine, obsidan
  • cholinolytics – Atropa belladonna L. tinctura
  • antihistamines – tavegil, suprastin;
  • anxiolytics – tazepam;
  • vitamins В1, В6, Е;
  • steroid estrogens – estradiol dipropionate, estrone, ethinylestradiol, estriol;
  • gestagens (progestines) – progesterone, turinal, norcolut, premalut-nor, pregnin;
  • combined estrogen-gestagen drugs – bisecurin, non-ovlon;
  •  

 

Clinic characteristic of the patients.

Clinical study of Zhenoluten application efficiency was carried out at the Medical center of Saint Petersburg Institute of bioregulation and gerontology during the period from April till November 2011.        

            The participants of the clinical trial were 39 women at the age of 45-53 years with the climacteric syndrome diagnosis of light and moderate severity degree and 28 women at the age of 38-43 years with the exhausted ovary syndrome (early climacteric syndrome). 

The patients were complaining of hot flashes in the head and upper body, which were accompanied by increased perspiration, head ache and rise of arterial pressure, heart pain, chilly sensation, tachycardia at rest, proneness to syncope, nausea, heart “freezing” feeling, dizziness, and asthenia. Psychoemotional disorders were most frequently accompanied by irritation, easy crying, anxiety, sleep disturbances, defective memory and attention, rapid fatigability, decrease in physical and mental capacity. The patients have noted an increase in the frequency of respiratory infectious diseases.

Laboratory tests of the patients have shown disorders of hormonal status, characterized by increase in follicle-stimulating hormone and luteinizing hormone in the peripheral blood in patients with climacteric syndrome; thus the patients with exhausted ovary syndrome had several times increase in follicle-stimulating hormone and luteinizing hormone, it was accompanied by considerable decrease in estradiol amount in the peripheral blood.  General clinical and biochemical blood parameters were within the age norm.

All the patients were divided into 4 groups: 2 control and 2 basic according to the diagnosis. Patients of both control groups have been taking general therapy, which did not included hormonal drugs. Patients of both groups in addition to the general therapy have been taking Zhenoluten – 1 capsule 2 times a day at mealtimes for 30 days.

Methods of examination

We have been evaluating complaints of the patients, carried out general clinical blood analysis, and urine analysis, biochemical blood analysis using “REFLOTRON” device (Boehringer Mannheim, Germany). Ultrasonic examination of ovaries was carried out using Ultasonic device (ALOKA, Japan).  Hormonal content (FSH, LH and estradiol) in the blood serum was determined using radioimmunological method. Radioactivity of the samples was assessed using a counter “Tracor Analytic 1285” (USA-Holland).

 

 

Results of examination

            It was established that application of Zhenoluten in patients with mild and medium severity climacteric syndrome has resulted in improvement of the general condition, which manifested itself as a decrease in the number of hot flashes, better sleep and appetite, increase in working capacity (table 1).

Table 1

Dynamics of subjective parameters in patients with climacteric syndrome

Parameter

Number of patients, %

Before treatment

After treatment using general purpose medicines

(control group)

After treatment using Zhenoluten (basic group)

Hot flashes to the head and upper body

72,0

55,1*

31,8*#

Increased perspiration

67,8

50,7*

29,6*#

Rapid fatigability

68,8

51,3*

31,4*#

Reduced working capacity

81,6

53,1*

32,6*#

Irritation

91,8

54,2*

33,3*#

* р<0,05 – in comparison with the parameter for the patients before treatment;

# р<0,05 – in comparison with the parameter for the patients after treatment using general puprose medicines.

 

The laboratory study after application of Zhenoluten has shown reliable decrease in FSH and LH, which resulted in increase in LH/FSH index to the lower limits of the age-related physiological fluctuations (table 2).

            The identified changes of hormonal status of the patients due to administration of Zhenoluten correlate with clinical parameters and are indicative of restoration of the adequate adaptation reaction of the ageing organism in reply to age-related decrease in ovarian function.

 

                                                                                                                    Table 2

Influence of Zhenoluten on the blood serum pituitary hormones

in patients with climacteric syndrome

Parameter

Norm

Before treatment

After treatment using general methods

(control group)

After treatment

using 

Zhenoluten

 (basic group)

FSH, (mU/ml)

1,5-45

89,3±3,5

71,6±6,3*

46,8±3,9*#

LH, (mU/ml)

2-17

28,1±1,9

25,7±2,4

16,4±1,4*#

* р<0,05 – statistically significant in comparison with the parameter before treatment.

# р<0,05 – statistically significant in comparison with the parameter for the patients of control group.

 

            In patients with exhausted ovary syndrome administration of Zhenoluten in addition to the general purpose therapy in 67% of cases has resulted in normalization of the menstrual cycle, has resulted in a decrease in astheno-neurotic sigs of the disease.

            Table 3

Influence of Zhenoluten on the blood serum pituitary hormones

in patients with exhausted ovary syndrome

Parameter

Norm

Before treatment

After treatment using general methods

(control group)

After treatment

using 

Zhenoluten

 (basic group)

FSH, (mU/ml)

1,5-45

114,6±7,8

87,2±5,4*

56,4±2,9*#

LH, (mU/ml)

2-17

47,3±2,6

38,6±3,9

28,5±2,1*#

Estradiol, (pmol/l)

110-734

51,1±2,6

68,3±3,1*

88,2±4,1*#

* р<0,05 – significant in comparison with the parameter before treatment.

# р<0,05 – significant in comparison with the parameter for the patients of control group.

 

The results of laboratory tests are indicative of a tendency towards normalization of the ratio of FSH, LH and estradiol hormones (table 3). 

            Analysis of the data received results in a conclusion that Zhenoluten renders normalizing influence on the cellular metabolism in the ovarian tissues, it promotes formation and maturing of follicles, restoration of the reproductive system functions in women.

            Thus the results obtained confirm therapeutic efficiency of Zhenoluten and expedience of its application for complex treatment of the different age patients with climacteric syndrome and exhausted ovary syndrome.

            Administration of Zhenoluten has not resulted in any side effects, complications and drug dependence.

            Zhenoluten can be used for treatment and prophylactic in the form of biologically active food additive together with any means of symptomatic and pathogenetic therapy, used for treatment of climacteric syndrome and exhausted ovary syndrome.

 

Conclusion

 

            Biologically active food additive Zhenoluten normalizes functional activity of the ovarian cells.

            Zhenoluten is well tolerated at oral administration, does not have any side effects and can be used as treatment-prophylactic biologically active food additive.

            Zhenoluten is recommended for patients with climacteric syndrome and exhausted ovary syndrome, per os at mealtime 1-2 capsules 2 times a day for 30 days.

            If necessary a repeated course of treatment can be carried out in 3-6 month.

 

 

References

 

  1. Bodyazhina V.I., Smetnik V.P., Tumilovich L.G. Non-surgical gynecology: Manual for doctors. – М.: Medicine, 1990. – 544 pages.
  2. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical pharmacology and pharmacotherapy: Manual for doctors. – М.: Universum, 1993. – 398 pages.
  3. Mashkovsky M.D. Medicines: Pharmacotherapy manual for healthcare professionals: 2 parts – Vilnus: ZAO “Gamta”, 1993.
  4. Geriatrics manual / Edited by D.F. Chebotarev, N.B. Mankovsky. – М.: Medicine, 1982. – 544 pages.
  5. Tepperman J., Tepperman H. Metabolic and endocrine physiology: Translated from English –  М.: Mir, 1989. – 656 pages.

 

 

 

Recommendations for use

     Zhenoluten is a complex of peptides, received from ovaries of young animals.  The isolated peptides have selective effect on the ovarian cells, they normalize metabolism in the ovarian cells and regulate reproductive system functions in women. 

The clinical study has helped to establish an efficiency of Zhenoluten for complex treatment of the patients with climacteric syndrome and exhausted ovary syndrome, for restoration of the function of reproductive system in women after diseases of various origin, at influence of extreme environmental factors, hypoalimentation, and at ageing.

Zhenoluten should be taken per os at mealtime 1-2 capsules 1-2 times a day.  The period of administration makes 30 days.  It is reasonable to have a repeated course in 4-6 month.

        Contraindications: individual intolerance to the components, pregnancy, breast feeding.

Administration of Zhenoluten has not resulted in any side effects.

It is recommended to store in a dry dark place at the temperature from +2 up to +25ºС.

Pharmaceutical form: 20 capsules or tablets of Zhenoluten 10 mg each.

 Period of validity – 3 years from the day of manufacturing.

 

Executive officer:

Deputy Director of LLC “Medical Center of Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences” in charge of clinical affairs, Ph.D., assistant professor

 

 

 

 

________________________A.A. Veretenko

Action officer:

Chief Physician of LLC “Medical Center of Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences”, Ph.D.

 

 

 

 

_____________________O.Y. Raygorodsky

 

 

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—————————————————-Конец перевода документа—————————————————-

 

 

 

I, the undersigned certified translator Yurov Stanislav Igorevich, fluent in both Russian and English languages, confirm that the above is a true, accurate and complete translation of the attached document.

 

Я, дипломированный переводчик Юров Станислав Игоревич, владеющий русским и английским языками, подтверждаю, что выполненный мною перевод приложенного документа  является правильным, точным и полным.

 

Переводчик Юров Станислав Игоревич

Л МИХАЙЛОВИЧ

Подпись переводчика Юрова Станислава Игоревича подтверждаю

 

Предприниматель                                                                                              Чепурной В. Г.