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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for post-operative swelling, pain, and edema in patients who have undergone meniscus surgery. The treatment being tested is a medication called Aescuven, which contains a dry extract of horse chestnut. This extract is standardized to contain a specific amount of active compounds known as triterpene glycosides. The study will compare the effects of Aescuven to a placebo, which looks and tastes like the real medication but contains no active ingredients.

The purpose of the study is to determine if Aescuven can effectively reduce swelling, pain, and fluid buildup after meniscus surgery. Participants in the study will take four tablets of Aescuven daily, divided into two doses. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. This type of study is known as a double-blind trial.

Throughout the study, participants will have several visits where their knee’s condition will be assessed. These assessments will include measuring the knee’s volume and circumference, checking the range of motion, and evaluating the skin temperature at the surgery site. The study will also track the amount of pain medication used by participants and their overall quality of life during the trial period. The study aims to provide valuable information on the potential benefits of using Aescuven for managing post-surgical symptoms in meniscus surgery patients.

1 initial visit

Upon joining the study, you will attend an initial visit where the trial will be explained in detail. You will be asked to sign a consent form to confirm your understanding and willingness to participate.

Your age will be confirmed to ensure you are between 18 and 75 years old. Your diagnosis requiring meniscus arthroscopy will be reviewed to confirm eligibility for the study.

2 pre-surgery assessment

Before your scheduled knee surgery, you will undergo a pre-surgery assessment. This includes measuring the volume and circumference of your affected knee using optoelectronic methods and tape.

The range of motion of your knee joint will be assessed, and the skin temperature at the surgery site will be recorded.

3 surgery and immediate post-surgery

You will undergo the planned meniscus surgery. After the surgery, the volume of fluid drained from your knee will be measured.

You will begin taking the study medication, Aescuven, which consists of 4 coated tablets per day, taken as 2 tablets twice daily (b.i.d.).

4 post-surgery follow-up visits

You will attend several follow-up visits where the volume and circumference of your knee will be measured again. The range of motion and skin temperature will also be assessed.

You will continue taking the study medication as prescribed. Your usage of any pain relief medication will be recorded.

5 final visit

At the final visit, the volume of your affected knee will be measured one last time. You will complete a quality of life questionnaire to assess your overall well-being.

The effectiveness of the study medication will be evaluated by the investigator, and your participation in the study will conclude.

Who Can Join the Study?

The patient must have signed and dated a consent form after the trial was fully explained and understood.
The patient must be between the ages of 18 and 75 at the time of screening.
The patient must have a diagnosis that requires meniscus arthroscopy (a type of knee surgery) and be scheduled for this surgery on one knee within 5 months after the screening visit.
The patient must be willing and able to participate in the trial, follow the instructions given by the trial doctor, attend all visits, and agree to the procedures outlined in the trial plan.

Who Cannot Join the Study?

Patients who are not experiencing post-operative swelling, pain, and edema after meniscus surgery cannot participate. Edema means swelling caused by excess fluid trapped in the body’s tissues.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
MVZ Gelenk-Klinik Dres. Schneider Ostermeier & Partner Arzte-Partnerschaft	Gundelfingen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.01.2023

Trial locations

Investigated drugs:

Dry Extract Of Horse Chestnut, Standardised (Der 5-7:1), Adjusted To 12.5 Mg Of Triterpene Glycosides Calculated As Protoaescigenin, Extraction Solvent: Ethanol 50% (M/M)

Aescuven® is a medication made from horse chestnut seed extract. It is used in this clinical trial to see if it can help reduce swelling, edema, and pain after meniscus surgery. The idea is that this natural extract might help with the healing process by decreasing the amount of fluid that builds up in the tissues after surgery, which can cause discomfort and slow down recovery. Participants in the trial take this medication to see if it makes a difference in how quickly and comfortably they recover from their surgery.

Investigated diseases:

Post procedural swelling

Post-operative swelling, pain, and edema – This condition occurs after surgical procedures, such as meniscus surgery, and involves the accumulation of fluid in tissues, leading to swelling. The swelling is often accompanied by pain and a feeling of tightness or heaviness in the affected area. Edema is the medical term for this fluid buildup, which can result from the body’s inflammatory response to surgery. As the body heals, the swelling and pain typically decrease over time. The progression of this condition can vary depending on the individual and the extent of the surgery. Monitoring and managing these symptoms are important for recovery and regaining function in the affected area.

Trial ID:

2022-501154-11-00

Protocol code:

CES AES 01/21

Trial Phase:

Therapeutic exploratory (Phase II)

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