Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584799
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Venoactive Drug Treatment of Pelvic Venous Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Assessment of the Efficacy and Safety of Venoactive Drug Treatment of Pelvic Venous Disorders
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENOTREAT
Brief Summary:
Venoactive drug VAD therapy is one of the most effective methods of treating chronic venous diseases CVD Numerous studies have proven its high efficacy in relieving symptoms of CVD such as leg pain and swelling leg heaviness and fatigue Pelvic venous disorders PeVDs represent a group of pathological conditions including varicose veins of the pelvis and vulva and compression stenoses of the left renal and common iliac veins Although PeVDs are associated with venous lesions of the pelvis and retroperitoneum and have specific clinical manifestations they are one of the forms of CVD and constitute a separate cohort A number of studies on the VAD usage in PeVD indicate the wide possibilities of this type of treatment in eliminating chronic pelvic pain CPP the most dramatic symptom of PeVD which is the main cause of disability and decreased quality of life social and daily activity in women with PeVD Currently a variety of VADs are presented on the pharmaceutical market which according to the product labels provide effects not only on the venous outflow from the lower extremities but also on venous hemodynamics in the pelvis At the same time a literature analysis shows that micronized purified flavonoid fraction MPFF has the greatest evidence base obtained in the efficacy and safety studies of VADs in PeVD Nevertheless patients are rarely interested in the scientific dossier of drugs and in the real practice the patients with PeVD and CPP most often ask What is the best drug to use for the CPP relief This is quite understandable as it is CPP in PeVD that results not only in disability but also in family conflicts psycho-emotional stress and depressive states In this regard patients seek to get rid of pain as soon as possible and strive to use the most effective drug An extensive scientific base of comparative studies on the use of various VADs in patients with CVD and PeVD has been accumulated to date However the literature is lack of any data on the comparative efficacy and safety of VADs in the treatment of patients with PeVD This in turn makes not possible for doctors and patients to choose the optimal and most effective drug based on the objective research data All the above has predetermined the purpose of the planned study as evaluating the efficacy and safety of different VADs in the treatment of female patients with PeVD
Detailed Description:
Study objectives
To evaluate the efficacy of diosmin-containing VADs in the CPP relief in female patients with PeVD
To evaluate the safety by the number of side effects and adverse events of diosmin-containing VADs in female patients with PeVD
To compare the efficacy and safety of treatment with different diosmin-containing VADs
To evaluate the patients adherence to the different recommended diosmin-containing VADs in female patients with PeVD
Patients and methods A total of 150 female patients of reproductive age with symptomatic PeVD and without any other diseases accompanied by CPP are planned for the inclusion in the study
Clinical study All patients will be examined by an investigating physician Complaints medical history and physical examination results will be recorded in the individual patients case report form CRF The severity of CPP will be assessed using a 10-score visual analogue scale VAS before treatment and then weekly for 2 months of treatment with VAD
Diagnostic methods
All patients will undergo transabdominal and transvaginal duplex ultrasound study DUS of the pelvic veins
Treatment methods the following VADs will be used as the study drugs
1 Micronized purified flavonoid fraction 1000 Manufacturer SERVIER RUS LLC Russia Active substance micronized purified flavonoid fraction diosminflavonoids expressed as hesperidin
Micronized purified flavonoid fraction MPFF is a venotonic agent that also has angioprotective properties It reduces venous distensibility and blood stasis capillary permeability and increases capillary resistance The results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to the parameters of venous hemodynamics MPFF improves venous tone a reduction in venous emptying time has been shown by venous occlusion plethysmography In patients with signs of severe microcirculatory disorders the treatment with drugs containing this active substance is associated with a statistically significant as compared to placebo improvement in the capillary resistance as has been shown by angiostereometry The drug also has a proven efficacy in the treatment of CVD of the lower extremities Source httpswwwvidalrudrugsdetralex__38634 accessed September 4 2023
MPFF 1000 dosing regimen is 1000 mg once daily for 2 months
2 Diosmin 600 Manufacturer INNOTHERA CHOUZY France Active substance diosmin
Venotonic action the drug reduces venous distensibility increases venous tone reduces blood stasis and enhances the vasoconstrictor effect of epinephrine and norepinephrine The optimal daily dose of diosmin for obtaining venotonic effect is 600 mg
Angioprotective action the drug improves microcirculation increases capillary resistance and reduces capillary permeability Effect on the lymphatic system the drug improves lymphatic drainage increases the tone and frequency of contraction of lymphatic capillaries increases their functional density and reduces lymphatic pressure It has an anti-edematous effect reduces symptoms of inflammation dose-dependent effect reduces adhesion of leukocytes to the venous wall and their migration into paravasal tissues and improves oxygen diffusion and perfusion in tissues The drug hinders the production of free radicals and synthesis of prostaglandins and thromboxane A double-blind placebo-controlled study using Duplex ultrasound has confirmed that the drug reduces the mean venous pressure in the system of superficial and deep veins of the lower extremities Source httpswwwvidalrudrugsphlebodia_600__4622 accessed September 4 2023
Diosmin 600 dosing regimen is 600 mg once daily for 2 months
3 Hesperidin Diosmin 1000 Manufacturer ALLIUM Russia Active substance diosmin and hesperidin
A venotonic agent that also has angioprotective properties It reduces venous distensibility and blood stasis reduces capillary permeability and increases their resistance The results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to the parameters of venous hemodynamics It increases venous tone a reduction in the time of venous emptying has been demonstrated in studies with venous occlusion plethysmography In patients with signs of severe microcirculatory disorders the treatment with drugs containing this active substance is associated with a statistically significant as compared to placebo improvement in the capillary resistance which has been proven by angiostereometry The drug has a proven efficacy in the treatment of CVD of the lower extremities Source httpswwwvidalrudrugsgesperidin-diosmin accessed September 4 2023
Hesperidin Diosmin 1000 dosing regimen is 1000 mg once daily for 2 months All three of these drugs are venotonic and venoprotective drugs used in the CVD treatment They are comparable in their pharmacological properties product labels profile of side effects and adverse events and the cost per package of 30 tablets according to the Moscow chain of pharmacies Source httpsgorzdravorgpdetraleks-tabl-p-o-1000mg-n30-62440 httpsgorzdravorgpflebodia-600-tabl-p-o-600mg-n30-17602 httpsgorzdravorgpvenarus-tabl-p-o-900mg-100mg-n30-64844 accessed September 4 2023
Patients will take these VADs at the same time every morning during breakfast Patients will be warned in advance about possible side effects and adverse events In a case of their occurrence the patients shall immediately notify the principal investigator or investigators using one or more mobile phone numbers provided to them in advance
Methodology The study will include 150 consecutive female patients with symptomatic PeVD according to the inclusionnon-inclusion criteria All patients will undergo a clinical examination transabdominal and transvaginal DUS of the pelvic veins to verify the diagnosis and to determine the diameters of the pelvic veins and the duration of reflux in them The study will include patients with PeVD and isolated dilation and reflux in the parametrial and uterine veins Previous studies have shown that the use of VADs in patients with a combination of reflux in the ovarian parametrial and uterine veins is ineffective The CPP intensity will be assessed using a visual analogue scale VAS which is a 10-cm horizontal line ranged from 0 to 10 scores 1 cm equals 1 score The CPP intensity will be assessed by VAS scores as following 0 no pain 1-3 mild pain 4-6 moderate pain 7-10 severe pain After a brief instruction by an investigator the patients will rate their pain intensity by making a mark on the line
For randomization procedure the sealed envelope principle will be used Three groups of 50 patients each will be formed depending on the recommended VAD usage group 1 n50 with MPFF1000 group 2 n50 with Diosmin 600 and group 3 n50 with Hesperidin Diosmin 1000 After the start of VAD intake the patients will be self-rating the pain intensity on VAS on the weekly basis After 60 days from the VAD treatment start the patients will undergo repeated clinical examination and provide an investigator with 8 completed VAS forms Based on the repeated examination data and the VAS results a comparative analysis of the clinical efficacy of VADs will be carried out In a case of side effect or adverse event occurrence during a 2-month treatment course patients inform the doctor-investigator about it within one day and the decision is made either to continue change the regimen of treatment or to discontinue it
To evaluate the efficacy of diosmin-containing VADs in the CPP relief in female patients with PeVD
To evaluate the safety by the number of side effects and adverse events of diosmin-containing VADs in female patients with PeVD
To compare the efficacy and safety of treatment with different diosmin-containing VADs
To evaluate the patients adherence to the different recommended diosmin-containing VADs in female patients with PeVD
Patients and methods A total of 150 female patients of reproductive age with symptomatic PeVD and without any other diseases accompanied by CPP are planned for the inclusion in the study
Clinical study All patients will be examined by an investigating physician Complaints medical history and physical examination results will be recorded in the individual patients case report form CRF The severity of CPP will be assessed using a 10-score visual analogue scale VAS before treatment and then weekly for 2 months of treatment with VAD
Diagnostic methods
All patients will undergo transabdominal and transvaginal duplex ultrasound study DUS of the pelvic veins
Treatment methods the following VADs will be used as the study drugs
1 Micronized purified flavonoid fraction 1000 Manufacturer SERVIER RUS LLC Russia Active substance micronized purified flavonoid fraction diosminflavonoids expressed as hesperidin
Micronized purified flavonoid fraction MPFF is a venotonic agent that also has angioprotective properties It reduces venous distensibility and blood stasis capillary permeability and increases capillary resistance The results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to the parameters of venous hemodynamics MPFF improves venous tone a reduction in venous emptying time has been shown by venous occlusion plethysmography In patients with signs of severe microcirculatory disorders the treatment with drugs containing this active substance is associated with a statistically significant as compared to placebo improvement in the capillary resistance as has been shown by angiostereometry The drug also has a proven efficacy in the treatment of CVD of the lower extremities Source httpswwwvidalrudrugsdetralex__38634 accessed September 4 2023
MPFF 1000 dosing regimen is 1000 mg once daily for 2 months
2 Diosmin 600 Manufacturer INNOTHERA CHOUZY France Active substance diosmin
Venotonic action the drug reduces venous distensibility increases venous tone reduces blood stasis and enhances the vasoconstrictor effect of epinephrine and norepinephrine The optimal daily dose of diosmin for obtaining venotonic effect is 600 mg
Angioprotective action the drug improves microcirculation increases capillary resistance and reduces capillary permeability Effect on the lymphatic system the drug improves lymphatic drainage increases the tone and frequency of contraction of lymphatic capillaries increases their functional density and reduces lymphatic pressure It has an anti-edematous effect reduces symptoms of inflammation dose-dependent effect reduces adhesion of leukocytes to the venous wall and their migration into paravasal tissues and improves oxygen diffusion and perfusion in tissues The drug hinders the production of free radicals and synthesis of prostaglandins and thromboxane A double-blind placebo-controlled study using Duplex ultrasound has confirmed that the drug reduces the mean venous pressure in the system of superficial and deep veins of the lower extremities Source httpswwwvidalrudrugsphlebodia_600__4622 accessed September 4 2023
Diosmin 600 dosing regimen is 600 mg once daily for 2 months
3 Hesperidin Diosmin 1000 Manufacturer ALLIUM Russia Active substance diosmin and hesperidin
A venotonic agent that also has angioprotective properties It reduces venous distensibility and blood stasis reduces capillary permeability and increases their resistance The results of clinical studies confirm the pharmacological activity of drugs containing this active substance in relation to the parameters of venous hemodynamics It increases venous tone a reduction in the time of venous emptying has been demonstrated in studies with venous occlusion plethysmography In patients with signs of severe microcirculatory disorders the treatment with drugs containing this active substance is associated with a statistically significant as compared to placebo improvement in the capillary resistance which has been proven by angiostereometry The drug has a proven efficacy in the treatment of CVD of the lower extremities Source httpswwwvidalrudrugsgesperidin-diosmin accessed September 4 2023
Hesperidin Diosmin 1000 dosing regimen is 1000 mg once daily for 2 months All three of these drugs are venotonic and venoprotective drugs used in the CVD treatment They are comparable in their pharmacological properties product labels profile of side effects and adverse events and the cost per package of 30 tablets according to the Moscow chain of pharmacies Source httpsgorzdravorgpdetraleks-tabl-p-o-1000mg-n30-62440 httpsgorzdravorgpflebodia-600-tabl-p-o-600mg-n30-17602 httpsgorzdravorgpvenarus-tabl-p-o-900mg-100mg-n30-64844 accessed September 4 2023
Patients will take these VADs at the same time every morning during breakfast Patients will be warned in advance about possible side effects and adverse events In a case of their occurrence the patients shall immediately notify the principal investigator or investigators using one or more mobile phone numbers provided to them in advance
Methodology The study will include 150 consecutive female patients with symptomatic PeVD according to the inclusionnon-inclusion criteria All patients will undergo a clinical examination transabdominal and transvaginal DUS of the pelvic veins to verify the diagnosis and to determine the diameters of the pelvic veins and the duration of reflux in them The study will include patients with PeVD and isolated dilation and reflux in the parametrial and uterine veins Previous studies have shown that the use of VADs in patients with a combination of reflux in the ovarian parametrial and uterine veins is ineffective The CPP intensity will be assessed using a visual analogue scale VAS which is a 10-cm horizontal line ranged from 0 to 10 scores 1 cm equals 1 score The CPP intensity will be assessed by VAS scores as following 0 no pain 1-3 mild pain 4-6 moderate pain 7-10 severe pain After a brief instruction by an investigator the patients will rate their pain intensity by making a mark on the line
For randomization procedure the sealed envelope principle will be used Three groups of 50 patients each will be formed depending on the recommended VAD usage group 1 n50 with MPFF1000 group 2 n50 with Diosmin 600 and group 3 n50 with Hesperidin Diosmin 1000 After the start of VAD intake the patients will be self-rating the pain intensity on VAS on the weekly basis After 60 days from the VAD treatment start the patients will undergo repeated clinical examination and provide an investigator with 8 completed VAS forms Based on the repeated examination data and the VAS results a comparative analysis of the clinical efficacy of VADs will be carried out In a case of side effect or adverse event occurrence during a 2-month treatment course patients inform the doctor-investigator about it within one day and the decision is made either to continue change the regimen of treatment or to discontinue it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None