Post procedural swelling Trials in Disease

Study on the Effects of Horse Chestnut Seed Extract on Swelling and Pain in Patients After Meniscus Surgery

This trial is investigating whether a natural medication called Aescuven, made from horse chestnut seed extract, can help reduce swelling, pain, and fluid buildup after meniscus surgery on the knee.

Who can participate:

• Adults between 18 and 75 years of age
• Patients scheduled to have meniscus arthroscopy (a type of knee surgery) within 5 months of the screening visit
• Individuals who understand the trial and can attend all required visits and follow the instructions provided by the trial doctor

Who cannot participate:

• Patients who are not experiencing swelling, pain, and fluid buildup after their surgery
• People outside the specified age range
• Members of vulnerable populations, such as children, pregnant women, or those unable to provide informed consent

What the trial involves:

The study compares Aescuven to a placebo, which looks and tastes like the real medication but contains no active ingredients. Neither participants nor researchers know who receives which treatment during the study, ensuring unbiased results. This is called a double-blind trial.

Participants take four tablets of their assigned treatment daily, divided into two doses. Throughout the study, several assessments take place to measure the knee's condition, including its volume and circumference, range of motion, and skin temperature at the surgery site. The amount of pain medication used and overall quality of life are also tracked.

The trial follows a structured timeline with multiple visits. The first visit involves explaining the study and confirming eligibility. Before surgery, the knee is measured and assessed. After the meniscus surgery, participants begin taking the study medication. Follow-up visits continue to monitor the knee's healing, and at the final visit, the effectiveness of the treatment is evaluated.

Investigational drug: Aescuven is made from horse chestnut seed extract standardized to contain specific active compounds called triterpene glycosides. The extract is thought to work by improving blood circulation and reducing fluid retention, which may help decrease swelling and pain after surgery.