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Completed

NCT Number: NCT06579482

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

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.

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Key information

Conditions

Chronic Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • 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

Treatment and study plan

Aesculus hippocastanum, and associations

Drug

combination product

Other names: no other intervention names

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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".

  5. 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".

Sponsors and collaborators

Lead sponsor

Fundação Educacional Serra dos Órgãos

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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