Herbal mix challenges standard drug for leg vein relief
NCT ID NCT06579482
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a combination of herbal ingredients (horse chestnut, polygonum acre, smilax pepyracea, and rutin) works as well as a standard drug (diosmin and hesperidin) for easing leg symptoms from chronic venous insufficiency. 120 adults with mild to moderate vein disease took one of the two treatments for 3 months. The main goal was to see if the herbal blend was not inferior in reducing leg pain, heaviness, and swelling.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- herbal blend (horse chestnut, polygonum acre, smilax pepyracea, rutin)
- What this could lead to
- If it works, this could offer a natural alternative to standard drugs for relieving heavy, painful legs from vein disease.
- What could go wrong
- This is a small, completed Phase 4 trial with only 120 participants. The herbal blend may not be as effective as the standard treatment, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
120 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
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Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, 25964004, Brazil
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