The report on the medicine Cryomelt MN studies.

1. Researches of adaptation activity, allergenic properties andtoxicity of a medicine have been executed in Institute of toxicology of theRussian Federation Ministry of Public Healthin trial toxicological laboratory ofmedicinal medicines, food stuffs and installations of a circumambient ANALEKT (the accreditation certificate №ROSS.RU.0001.21 PN 38 for № 06008 from 22.01.99).

The conclusion

The carried out researches haveshown high adaptation efficacy - of a medicine Cryomelt MN. Under itsaffecting the muscle strength and - persistence at experimental animals areenlarged­. It is possible to explain the given phenomenon by the­ augmentationunder the influence of a medicine of stores ATF in a cardiac muscle and in a cross-striated musculation, and also by theactivation in these organs of processes of histoid-breath.

Cryomelt MN is recommended for the treatment of debilitatedpatients and for use in the sport medicine as an effective adaptogen.

The Study of allergenic properties of a medicine Cryomelt MN was done according to Methodicalreferences of allergenic properties' merit rating of pharmacological materials and Methodical directionsfor  pre-clinical studying of the new medicinesdeveloped from natural raw materials, Ministry of Public Health of the Russian Federation, 2000

The conclusion

As a result of studying of allergenic act of a medicine Cryomelt MN on Guinea pigs of both sexes it has been shown, that it does not causereaction of the general anaphylaxis at application even in doses, in 10 timesmore the therapeutic. Moreover, conjunctiva assays, reactions of degranulationof mast cells and reaction of cell-bound immune complexes were negative.

These data allow concluding, that the medicine Cryomelt MN does not possess any allergenic properties.

The Report

About an experimental research
of an acute toxicity of a medicine Cryomelt MN

The conclusion

The done experimental researches have shown, that the medicine Cryomelt MN at acute introduction to the experimental animal (to mice, rats, dogs)practically does not render toxic act.
The carried out researches testify to absence ofcontraindications on parameters of acute toxicity for clinical tests or medicalapplication of a medicine Cryomelt MN.

The Report

Study of antiviral activity of the medical Preparation Cryomelt MN on model of a virus ofherpes of 1 phylum.

Researches was done according to methodical instruction "Testmethods and assessments of antiviral activity of chemical compounds concerninga flu virus", approved by the Ministry of the Public Health of the USSR,1977.

The conclusion

As a result of the study it was revealed:

1. Medicine Cryomelt MN; does not possess toxicity for crops of cells VeroE-6 and Hep-2.

2. MedicineCryomelt MN rendered an appreciable inhibiting effect on areproduction of a virus of herpes in tissue  crops during the first hours after infestation(not less than 80 % at 1 ITD, at massive infestation of 60 %), that assumespossibility of medicine's successful use in clinic.
3. Use of medicine Cryomelt MN; in a complex even with small doses ofan antiviral drug Zovirax raises an index of protection of cells from abecoming infected by the virus up to 100 %.
Revealing of the given fact very important in clinical medicine sincegives the chance to lower a dose of high-toxic medicine Zovirax at complex use ofZovirax andCryomelt MN at herpetic infection contaminations.
4. Experimentally also it has been revealed, that introduction of medicineCryomelt MN; in tubes with monolayer cellular crops stabilize the рН , and also improves the  viability of cells, that, probably, is boundto intensifying of a membrane potential of cells and their metabolism. Thegiven fact can play the important role at its use in cultivation of cells andvirologist researches.

Clinical study of a medicine Cryomelt MN was done inMedical centre of the President of Russian Federation (Moscow) and in MedicalAcademy of the postgraduate formations of Ministry of Health (Sankt -Petersburg) by the instructions of Pharmacological State Committee.

The Report

About studying of clinicalefficacy of a medicine Cryomelt MN at patients with steatohepatitis ofa various etiology
Moscow, 2004.

Conclusion.

The medicine Cryomelt MN; can be recommended to application and registration as a powerful medicine  for treatment of the steatohepatitis  of the alcoholic, metabolic and admixed etiology and for viralhepatitis' treatment as well.
 
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

The Report

Clinical study of efficacy andsafety of the medicine Cryomelt MN at the liver's diseases treatment.

The conclusion

Results of clinical,laboratory and instrumental researches on application - of medicine Cryomelt MN in treatment of patients with a chronic hepatitis of the alcoholic and admixed etiology show a widespectrum of the biological-propertiesproviding the liver's protective effect.
Normalization of subjective and objective clinicalsymptoms of a liver’s lesion againsttreatment by an investigated medicine was observed in earlier terms, thanagainst application of a medicine of comparison - . Parameters of cytologic,cholestatic syndromes of a lesion of a liver (the ALT, the AST, bilirubin,­ thegiven ultrasonic of organs of an abdominal lumen) after  the treatment's course within - three weekstestify  their normalization andauthentic difference with the analogous - data of the control group tendingonly to normalization to - specified term of therapy.Cryomelt MN is a safetymedical preparation which can be used forpathogenesis therapy of various diseases-of a liver.

Cryomelt MN; has successfully passed clinical tests, has the Registration certificate № LS-000135 from 07.06.2010,given out by Federal Service on supervision in sphere of public health servicesand social development.Cryomelt MN was entered in to the State catalogue ofmedical preparations, according to the Federal law from 22.06.98 № 86-FZ, andit is allowed for exhaustion when due hereunder in the reference, according tothe solution on the state registration.