Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chro… (NCT06579482) | Clinical Trial Compass
CompletedPhase 4
Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency
Brazil120 participantsStarted 2024-11-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs
. 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.
. For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.
. Patient read, understood, signed and dated the free and informed consent form
Exclusion criteria
. Treatment with compression stockings within 2 months of study inclusion date
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Treatment with venotonics within 2 months of the date of inclusion in the study
. Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
. Known allergy or hypersensitivity to any component of the study drug
. Known significant laboratory abnormality
. CEAP Grade Assessment of level 4, 5, or 6.
. Patient with venous disease requiring intravenous chemical surgery/sclerotherapy
. 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