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
- Conditions
- post-operative swelling, pain and edemaMedDRA version: 21.1Level: PTClassification code: 10066415Term: Post procedural swelling Class: 100000004863MedDRA version: 20.1Level: LLTClassification code: 10054711Term: Postoperative pain Class: 10022117MedDRA version: 21.1Level: LLTClassification code: 10063647Term: Post procedural edema Class: 10022117Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2022-501154-11-00
- Lead Sponsor
- Cesra Arzneimittel GmbH & Co. KG
- Brief Summary
Summary of results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: To assess the impact of Aescuven® on swelling at different time points and on additional clinical parameters linked to meniscus surgery, To assess tolerability and safety of Aescuven® in the therapy of swelling after meniscus surgery;Primary end point(s): Volume of the affected knee at visit 5, as determined by optoelectronic measurements, Patient reported outcome measures at visit 5 (co-primary endpoint)
- Secondary Outcome Measures
Name Time Method