Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and tolerability of horse chestnut seed extract on swelling in patients undergoing meniscus surgery: a placebo-controlled, randomized, double-blind, single-center, pilot study

This is a study for people having knee surgery, specifically for problems with their meniscus. Researchers want to find out if tablets made from horse chestnut seeds can help reduce swelling and pain after the operation. They will compare these tablets to others that look identical but contain no active ingredient, often called a placebo. This helps them see if any improvements are due to the horse chestnut or other factors. Participants' knee size will be measured carefully, and they'll also share how they feel about their pain and recovery. The study aims to understand if this treatment is effective and safe for people recovering from knee surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cesra Arzneimittel GmbH & Co. KG, Cesra Arzneimittel GmbH & Co. KG

Enrolment target

Start

13 Feb 2023

post-operative swelling pain and edema

What is this study about?

Imagine you're having an operation on your knee, perhaps because of a problem with the cartilage called the meniscus. After surgery, it's very common for the knee to swell up and feel painful. This study is exploring a potential way to help with that.

Researchers want to see if a natural extract from horse chestnut seeds, given as a tablet, can help reduce this swelling and pain. They're comparing it to a "dummy" tablet, which looks exactly the same but doesn't contain any active medicine. This is a common and important step in research, as it helps doctors understand if the horse chestnut is truly making a difference or if people just feel better because they're taking a tablet.

The main things they'll be looking at are how much the knee swells up and how you feel about your pain and recovery. They'll measure your knee carefully and ask you about how you're feeling and your quality of life. This type of study is an early-stage investigation, meaning it's helping researchers decide if this treatment shows enough promise to be studied in more detail later on.

Key takeaways

Tests if horse chestnut helps post-knee surgery swelling and pain.
Compares horse chestnut tablets to a dummy pill.
Involves regular knee measurements and well-being checks.
Aims to find out if this treatment is safe and effective.
For adults having meniscus knee surgery.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. People will be included if they are planning to have surgery on their meniscus, which is a type of cartilage in the knee.

Specific medical conditions or medications might prevent you from joining, but these will be discussed in detail by the study team. They need to make sure the study is safe for you and that the results will be clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you planning to have surgery on your knee's meniscus?
Are you able to attend all study visits?
Are you generally healthy enough to participate in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the horse chestnut tablets or a dummy pill. You won't know which one you're getting, and neither will your study doctor, to keep the results fair. You'll take these tablets as instructed.

You'll have several visits over the course of the study. There will be visits before your surgery, during which they'll measure your knee and ask you about how you feel. After your surgery, you'll have more visits where they'll continue to measure your knee's swelling and movement, check your pain levels, and ask you about your recovery and quality of life. They might use special equipment to measure your knee's size and also use a tape measure. They'll also check your skin temperature at the surgery site. Throughout the study, you'll also be asked about any pain relief medication you're using. The study will last for a certain period after your surgery, with a final visit to assess your progress.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might find that the horse chestnut tablets help reduce your swelling and pain, potentially speeding up your recovery. However, there's also a chance you might receive the dummy pill and not experience any direct medical benefit from the study treatment itself. There could be side effects from the horse chestnut tablets, although generally they are considered mild. You will be closely monitored for any reactions or changes in your health. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is meniscus surgery?

It's an operation on a C-shaped piece of cartilage in your knee called the meniscus, often done to fix a tear.

What is horse chestnut extract?

It's a natural substance taken from horse chestnut seeds, sometimes used to help with swelling.

What is a 'dummy pill'?

It's a tablet that looks real but contains no active medicine. It helps researchers compare effects fairly.

How will they measure my knee swelling?

They will use special light-based measurements and also traditional tape measures to check the size of your knee.

Will I know if I'm getting the real medicine or the dummy pill?

No, you won't. This is called 'double-blind' and helps make sure the results are as accurate as possible.