Investigation of the effects of cartilage structure nutrients on symptoms of knee osteoarthritis: a 12-weeks, randomized, double-blind, placebo-controlled pilot study - BTS1834/22

Apomedica Pharmazeutische Produkte GmbH0 个研究点目标入组 54 人开始时间: 2022年7月12日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Main inclusion criteria:
•Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
•Sex: female and male (minimum 25% of each gender)
•Subjects with primary osteoarthritis who are not expected to require surgical treatment for at least three months after inclusion.
•Known X-ray or MRI finding (Kellgren score of 1 to 3; X-ray or MRI not older than 36 months)
•Discomfort over a period of at least 3 months
•KOOS pain score with maximum 75 (Maximum 100 (no pain problems)) at screening
•Age: 40 – 75 years
•BMI: 19 – 32 kg/m2
•Subjects agree to maintain physical activity levels throughout the study
•Except for osteoarthritis, the subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, hematology

•Main exclusion criteria
•Inflammatory, infectious or metabolic joint disorder
•Artificial joint replacement in knees or hip
•Surgery within the last 6 months in knees or hip
•Intra-articular therapy within the last 3 months
•Oral cartilage treatment within the last 3 months including also supplements e.g. glucosamine, chondroitin, hyaluronic acid or collagen.
•Medical treatment of joint disease besides Paracetamol as analgesic medication for emergency treatment
•Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), heavy depression, significant cardiovascular disease or co-morbidities (e.g. myocardial infarction, stroke, congestive heart failure), diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin, etc.)
•Present or recent use of drugs and dietary supplements with anti-inflammatory properties that could interfere with the study 2 months before or during the study (e.g. Curcumin, omega-3 FA, chronic intake of NSAR, ibuprofen, glucocorticoids (except inhalative) etc.), antioxidative supplements (e.g. vitamin C, vitamin E) or further antioxidative supplements (e.g. OPC etc.).

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