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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
EU CTIS ID: 2022-501154-11-00
What this study is testing
To investigate whether Aescuven®, at a dose of 4 tablets per day (2 coated tablets b.i.d.), decreases post-operative swelling, edema, and pain after meniscus surgery
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Presence of the consent form personally signed and dated by the subject after the nature of the trial was fully explained by the Investigator and understood by the subject
- Age: 18 – 75 years at time of screening
- Diagnosis requiring meniscus arthroscopy, eligible and scheduled for unilateral knee surgery within max. 5 months after screening visit
- Willing and able to participate in the trial, to follow the instructions by the Investigator, to attend the visits and to agree to the procedures foreseen in the protocol.
You likely can't join if
- Using compression stockings
- Pregnant or breastfeeding
- Not using any accepted method of contraception
- Arthrosis of knee joint (Kellgren-Lawrence grade > grade II)
- Participation in another clinical trial within the 2 months preceding enrolment in this trial and/or during trial participation
- Member of site staff or trial team (Sponsor, CRO) directly involved in the trial conduct and their family members
See the full eligibility criteria
- Presence of the consent form personally signed and dated by the subject after the nature of the trial was fully explained by the Investigator and understood by the subject
- Age: 18 – 75 years at time of screening
- Diagnosis requiring meniscus arthroscopy, eligible and scheduled for unilateral knee surgery within max. 5 months after screening visit
- Willing and able to participate in the trial, to follow the instructions by the Investigator, to attend the visits and to agree to the procedures foreseen in the protocol.
- Using compression stockings
- Pregnant or breastfeeding
- Not using any accepted method of contraception
- Arthrosis of knee joint (Kellgren-Lawrence grade > grade II)
- Participation in another clinical trial within the 2 months preceding enrolment in this trial and/or during trial participation
- Member of site staff or trial team (Sponsor, CRO) directly involved in the trial conduct and their family members
- Muscle rupture/muscle hematoma
- History of vascular surgery or arteriosclerosis
- Vascular disease of the legs (e.g. phlebitis, thrombosis, varicosis)
- Lymphatic disease of the legs (lymphedema, erysipelas)
- Lipedema of the legs
- Complex Regional Pain Syndrome (CRPS: Morbus Sudeck)
- Acrodermatitis chronica atrophicans
- Chronic Obstructive Pulmonary Disease (COPD)
- Current infection with SARS-CoV-2
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Physiological edema (myocardial insufficiency, renal insufficiency, liver cirrhosis, nutritional/protein deficiency edema/bulimia, thyroid deficiency/Grave’s disease, Cushing Syndrome)
- Other significant or insufficiently treated gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, as judged by the Investigator
- History of allergy/hypersensitivity to the trial medication, including intolerance to lactose
- Diagnosis of epilepsy
- BMI ≥ 30
- Alcoholism
- Under treatment with any drugs or food additives that might influence the results of the trial during the four weeks before start of the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.