CTIS2022-501154-11-00进行中（未招募）1 期
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 - CES AES 01/21
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
Summary of results
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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