Chronic Venous Insufficiency
Conditions
Brief summary
To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.
Detailed description
Phlebotonics represent a heterogeneous group of therapeutic products of natural or synthetic origin that exhibit effects on edema and/or symptoms related to chronic venous diseaseThis class of drugs is effective in improving the symptoms of chronic venous insufficiency and in cases of hemorrhoids and for this reason they have become an established component of the therapeutic arsenal for all phases of these diseases Phlebotomics are classified into four categories: benzopyrones, saponins, other plant extracts, and synthetic drugs
Interventions
DRUGAesculus hippocastanum, and associations
combination product
Sponsors
Fundação Educacional Serra dos Órgãos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
coated tablets
Intervention model description
Randomized, non-inferiority, double-blind ,comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs 2. Clinical symptoms of chronic venous insufficiency of the lower limbs, defined by the 100mm visual scale performed by the patient between 20mm and 60mm in the most symptomatic lower limb. 3. For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives. 4. Patient read, understood, signed and dated the free and informed consent form
Exclusion criteria
1. Treatment with compression stockings within 2 months of study inclusion date 2. Treatment with venotonics within 2 months of the date of inclusion in the study 3. Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period. 4. Known allergy or hypersensitivity to any component of the study drug 5. Known significant laboratory abnormality 6. CEAP Grade Assessment of level 4, 5, or 6. 7. Patient with venous disease requiring intravenous chemical surgery/sclerotherapy 8. Patient presenting with a painful pathology in addition to venous pain in the lower limbs 9. Patient with a history of thrombosis or thromboembolic disease within 6 months of the date of inclusion in the study 10\. Patient with a change in general condition that is incompatible with his/her participation in the study 11. Patient who wishes to become pregnant within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogic scale | 3 months | A 100 mm VAS (visual analogic scale) is marked from 0 (absence of venous symptoms) up to 100 (maximum symptomatic venous manifestations) by the patient (higher scores means a worse outcome). It is fulfilled by the patient him- or herself, under the physician's watch. VAS is meant to globally evaluate lower limbs venous symptomatology (heavy legs, painful legs, fatigued legs, deambulation limitations, swollen sensation and/or lower limbs tension). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral acceptability by the patient through the use of a visual analogic scale | 3 months | A 100 mm VAS (visual analogic scale) is marked from 0 (easy swallowing) up to 100 (very difficult to swallow) by the patient (higher scores means a worse outcome). It is fulfilled under by the patient him- or herself under the physician's watch. |
| Quality of life as measured by a specific chronic venous insufficiency questionnaire | 3 months | CIVIQ-10 (chronIc venous insufficiency quality of life questionnaire) is a questionnaire composed of 20 scored items (on a 4 point scale) that inform on the capacity of the patient of coping with daily routine tasks, regarding their lower limbs venous competence. The higher the score, the better the clinical outcome. |
| Medical tolerability to tested drugs as measured by the investigator | 3 months | Tolerability will be a measure of the nature and quantity of adverse clinical and lab reactions related to study drugs. |
| Patient's satisfaction to study medications | 3 months | This endpoint regards to the medication's efficacy as perceived by the patient and graduated as: insufficient, acceptable, good, or very good. |
| Physician's satisfaction to study medications | 3 months | This endpoint regards to the medication's efficacy as perceived by the investigating physician and graduated as: insufficient, acceptable, good, or very good. |
Countries
Brazil
Outcome results
None listed