Aesculus hippocastanum for the treatment of chronic venous insufficiency – an open study

Objective

The primary objective of the study is to assess the safety and tolerability of a new dosage regime for Aesculus Tablets (50 mg) in patients with chronic venous insufficiency (CVI). Efficacy is being explored as a secondary objective.

Materials and methods

The eliciting and recording of adverse events will be used to assess safety. Patients are being asked questions relating to their well-being and the safety (local symptoms) of the treatment preparation.

Both the patient and researcher are assessing tolerability using a four-point scale: good, fairly good, quite good and poor.

Efficacy is being explored by measuring changes in venous blood circulation of the affected lower limb. This is being assessed by photoplethysmography (PPG) and by measuring changes in the circumference of the ankle and of the lower leg.

Changes in symptom scores are also being recorded. This is being calculated on the basis of six symptoms indicative of status: sensation of heaviness or tension, pain, burning sensation, itching and paraesthesias.

Both the researcher and patient are carrying out overall general assessments of efficacy.

Results

Statistics generated will be general summary and descriptive statistics.

Conclusion

The study will hopefully prove that the new dosage regime, with a lower total daily aescin content, continues to provide adequate, long-term relief and result in improved, long-term patient compliance for the treatment of CVI.