Report on clinical trials anti varicose complex firms ART LIFE VENATOL.
LA Baziev, Assistant Department of Surgery SSMU, OA Ivchenko, MD, PhD, Head. Department of Surgery SSMU, Tomsk
Varicose veins - a widespread disease. Every fifth inhabitant of the planet is suffering from this disease. In fact, the bane of people of working age. The current traditional conservative treatment of varicose veins, unfortunately, does not have the desired effect, but long and continuous use of pharmaceuticals is often accompanied by various negative reactions in the body (side effects), and therefore highly relevant is the use of herbal drugs, especially in the early stages disease.
Based on the Department of Vascular Surgery EDO Tomsk conducted testing (clinical trials) of biologically active additives (BAA) VENATOL (antivarikoznogo phytocomplex) of "ART LIFE" (Tomsk).
Composition (1 capsule contains a mass of 0,6 g):
Buckeye 50 mg Rutin 25 mg
Ginko Biloba 10mg Quercetin 5 mg
Yves 12.5 mg Glutathione 2.5 mg
Vitamin E 5 mg 15 mg Glyukozminsulfat
Vitamin C 15mg Hesperidin 5 mg
Hawthorn 10 mg zinc sulfate 5 mg
Bromelain 1.5 mg of silicon oxide 10 mg
Common horse chestnut. Chemical composition: glycoside, esculin, fraksin, estsin, tannins, fatty oil, flavonoid glycosides (quercetin, izokvertsetin), starch. The main component - estsin - has expressed kapillyaroprotektornoy activity and anti-inflammatory and anti-edematous action. Estsin reduces lymph flow and simultaneously increases the solids content of lymph, reduces the permeability barrier plazmolimfaticheskogo. The presence of escin kapillyaroukreplyayuschee properties confirms the assumption that its predominant effect on the first phase of inflammation, which has been a violation of the vascular permeability. There is speculation that estsin antiexudative manifests its activity indirectly by stimulating the production and release of substance prostaglandinopodobnogo (PG-2).
Leaf extract of ginkgo biloba (EGB) has a complex chemical composition, which includes more than 40 ingredients, most important of which are flavonoid glycosides, terpene compounds, as well as ginkgolides and bilobalide. It is with these compounds bind specific pharmacological activity of EGB. Included in the EGB began acting possess a wide spectrum of pharmacological activity. EGB has sosudoreguliruyuschee effect on arteries, capillaries and veins. This activity depends on the diameter of the vessel, the structure of the vascular wall and its original tone. EGB prevents spasm of the arteries, veins increases, decreases capillary permeability, normalizing their tone. EGB modifies the rheological properties of blood: reducing the aggregation of platelets and red blood cells and thrombus formation in microcirculatory bed, as an inhibitor of trombotsitaktiviruyuschego factor, which plays an important role in the mechanism of platelet aggregation.
Willow bark extract has anti-inflammatory (contains the glycoside salicin), deprived of the side effects inherent to NSAIDs, because
• salicylates in plants glikozidirovany
• contain different classes of compounds (flavonoids, organic acids), which weaken its negative effects. Has a hemostatic effect due to the presence of tannins and astringents.
Bromelain - plant enzyme that catalyzes the carbohydrate and fat metabolism, has anti-inflammatory properties.
Hawthorn extend peripheral vessels, reduce blood cholesterol.
Complex of plant bioflavonoids (quercetin, hesperidin, rutin) prevents release of histamine granules, decreases the synthesis of leukotrienes, thereby providing anti-inflammatory effect; strengthens capillary walls and normalizing their permeability has an antioxidant effect.
Bioflavonoids - synergists Vitamin C in the formation of collagen - the substance that determines the mechanical properties of connective tissue and, hence, vascular permeability.
Vitamin E - the main fat-soluble antioxidant. In his presence, activity and effectiveness of antioxidants other groups (vitamin C, bioflavonoids) increases substantially. Vitamin E normalizes the process of blood clotting, improves circulation, promotes the development of collaterals.
Vitamin C - the main water-soluble antioxidant, is a pioneer in the formation of collagen - the main structural protein of connective tissue.
Glutathione - tripeptide actively involved in many redox reactions in the body and maintain a series of 8H-dependent enzymes.
Glyukozaminsulfat, easily assimilating rapidly enters the blood, which is involved in the formation of connective tissue (blood vessels).
Action antivarikoznogo phytocomplex aimed at reducing capillary permeability, inflammation, increased tone of the veins.
BAA ART LIFE VENATOL issued in the form of pellets, packed in a gelatin capsule. Pellets are tiny granules of regular shape, where the active components deposited in layers in a certain order on a neutral carrier, each layer is protected with a special film to regulate the consistency and speed the release of substances. The purpose of this study was to investigate the possibility of using and evaluating the effectiveness antivarikoznogo VENATOL complex in patients with varicose disease of lower extremities.
Objectives: To estimate the efficiency of using dietary supplements VENATOL in patients with varicose veins of the lower extremities of various stages, the study of tolerability and evaluation of its organoleptic properties.
The observation of 30 patients with varicose disease of lower limbs in various stages of age from 23 to 58 years, including 22 women and 8 men. Before treatment, all patients in the hospital conducted the following laboratory tests: complete blood count, general urinalysis, blood coagulation system. Patients varicosity in the compensation stage laboratory data were within normal limits, with the progression of the disease (stage subcompensation and decompensation), a tendency to hypercoagulation. After treatment for 2 or 3 days of tests were taken again.
Patients were divided into 2 groups - primary (15) and control (15). 7 patients of the main group took VENATOL in combination with desagregants (trental) and antioxidants (vitamins A, E, C) and 8 other people as a monotherapy.
In the control group patients received only disaggregants and antioxidants.
VENATOL prescribed 1 capsule 3 times daily for 3 to 4 weeks.
The results of laboratory data in the dynamics of the reaction clotting tendency towards a normalization of its performance in patients and control group. Action VENATOLA patients from group in combination with desagregants intensified anticoagulation effect.
Of the 8 patients of the group taking supplements VENATOL as monotherapy with varicose disease (stage of compensation), 7 (87,5%) reported disappearance of subjective symptoms (pain in the lower extremities, fatigue, heavy legs, night cramps) during treatment . The good tolerability VENATOLA, no side effects. In 1 patient (12.5%) of the positive effect was not.
It should be noted that the use of dietary supplements VENATOL as monotherapy at least 3 weeks of appearing effect of drug withdrawal, ie, the emergence of new complaints disappeared after stopping the supplements.
At longer taking supplements VENATOL effect of drug discontinuation was not.
Of the 7 observed the main group with a combined intake VENATOLA - in 5 (71%) was found positive effects (decreased swelling, itching disappeared, declined or disappeared heaviness in the legs. In 2 patients (29%), the effect was absent, these patients had chronic venous insufficiency in stage of decompensation.
In the control group, where VENATOL not taken, the positive effects were 9 patients and 6 show the previous complaints.
Clinical trials BAA ART LIFE VENATOL "showed good tolerability phytocomplex, no side effects while taking it.
The use of dietary supplements "VENATOL" shown in patients with varicose disease of lower limbs at any stage of the disease. Patients with varicose veins of lower extremities in the stage of compensation - in the form of monotherapy, and in the stage of decompensation subcompensation and demonstrates the use of VENATOL in combination with desagregants and antioxidants. Recommended dosage: 1-2 capsules 2-3 times daily. The course is at least 1 month.
The drug can be used as a preoperative preparation.
Studies on the effect antivarikoznogo VENATOL complex on the hemostatic system.
Based on the Department of Vascular Surgery bureau was to study the influence of dietary supplement VENATOL "on the hemostatic system in a separate group of patients. As a basic method of investigation used the analyzer PDP-01 "Mednord. Integral assessment of all phases of coagulation and fibrinolytic activity of blood was carried out according to research the state of aggregation before and after use of dietary supplements. Blood sampling was performed from the cubital vein. The studies were performed in 20 patients with a female aged 25 to 50 years with varicose disease of lower extremities in the stage subcompensation (study group).
Patients of the main group took supplements "VENATOL" 1 capsule 3 times a day for a month. The control group consisted of 20 healthy volunteers of similar age and gender.
Studies of the hemostatic system before and after using the supplement "Venatol (see Table.) Demonstrated that patients with varicose observed structural and chronometric hypercoagulability due to an increase in the number of fibrinogen, an increase of spontaneous platelet aggregation (Ag). Also revealed increased thrombin activity (QA ratio 10 ° / h) and acceleration of thrombus formation, activation of the 1 (d) and 11 (a) of the phases of blood coagulation, ie, process reflects the prothrombin activity of the blood and the start time of clot formation. In this fibrinoloticheskaya activity of blood (g) remained relatively low.
After applying the BAA "VENATOL" a decrease in blood coagulation potential, manifested reduced thrombin activity (CK), an extension of r and k, and a simultaneous increase in total lytic activity of blood (m).
Conclusion: The course taking supplements ART LIFE VENATOL causes a decrease in blood coagulation potential, which is associated with activation of the anticoagulation system.