Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency

January 2, 2026 updated by: Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos

Clinical Study of Non-inferiority Between Aesculus Hippocastanum 50mg, Polygonum Acre 10mg, Smilax Pepyracea 40mg, Rutin 20mg Versus Diosmin 450mg and Hesperidin 50mg Tablets in Chronic Venous Insufficiency After 3 Months of Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Teresópolis, Rio de Janeiro, Brazil, 25964004
        • Centro Universitário Serra dos Órgãos - UNIFESO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, and Rutina
Aesculus hippocastanum 50mg, Polygonum acre 10mg, Smilax Pepyracea 40mg, Rutina 20mg
Drug: Aesculus hippocastanum, and associations
combination product
Other Names:
  • no other intervention names
Active Comparator: Diosmina, and Hesperidina
Diosmina 450mg e Hesperidina 50mg
Drug: Aesculus hippocastanum, and associations
combination product
Other Names:
  • no other intervention names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogic scale
Time Frame: 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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral acceptability by the patient through the use of a visual analogic scale
Time Frame: 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.
3 months
Quality of life as measured by a specific chronic venous insufficiency questionnaire
Time Frame: 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.
3 months
Medical tolerability to tested drugs as measured by the investigator
Time Frame: 3 months
Tolerability will be a measure of the nature and quantity of adverse clinical and lab reactions related to study drugs.
3 months
Patient's satisfaction to study medications
Time Frame: 3 months
This endpoint regards to the medication's efficacy as perceived by the patient and graduated as: "insufficient", "acceptable", "good", or "very good".
3 months
Physician's satisfaction to study medications
Time Frame: 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".
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundação Educacional Serra dos Órgãos

Investigators

  • Principal Investigator: Carlos Nunes, Professor, Fundação Educacional Serra dos Órgãos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50635421.30000.5248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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