A polyherbal supplement (OsteolynÃ?Â®) for control of pain in the recent onset primary knee osteoarthritis subjects

Herbalyn Lifesciences Inc0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•a. Male or female Subjects 18 to 60 years, both inclusive
•b. Subject with diagnosis of primary OA Knees and not due to other local anatomical conditions such as bursitis, tendonitis, etc.,
•c. Symptoms for at least 3 months prior to screening
•d. The pain in the knees requires the use of pharmacological treatment
•e. After discontinuing all pain medications for at least 2 days, had at least moderate pain on movement (POM) for knee, defined as a baseline score of Ã¢â?°Â¥ 50 mm on a 0-100 mm Visual Analog Scale (VAS) immediately prior to randomization, and a baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of at least 9 immediately prior to randomization.
•f. Subject is willing to replace all current pain medications with rescue medication for use if needed during the duration of the study [subjects should be able to withhold all rescue medication (to be confirmed) use for at least 24 hours prior to all WOMAC pain score assessments at study visits].
•g. Subject is well-motivated, capable, and willing to: a) willing to replace all current medications a) learn how to self-administer study treatment (Etodolac 200 mg Tablet, OsteolynÃ?Â® or placebo) and b) maintain a study diary

•a. Pregnant or lactating or planning to become pregnant and women with reproductive potential unwilling to follow standard contraception methods.
•b. History of any form of secondary arthritis and complication of osteoarthritis
•c. History of rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
•d. History of established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, congestive heart failure
•e. History of asthma, hypertension, thrombotic events, stroke, impaired cognitive function, impaired renal function and impaired hepatic function.
•f. History of gastrointestinal bleeding or peptic ulcer disease.
•g. Known hypersensitivity to Aspirin and/or NSAID.
•h. History of tobacco, drug and alcohol abuse
•i. History of use of systemic and topical pain medications (to knees) in the four weeks prior to randomization.
•j. Application of moisturizers, sunscreen, creams, lotions, powders or any topical (medicated or cosmetic) product the treatment knee area for duration of study.
•k. History of major knee surgery or injury of knee or any form of inflammatory arthritis.
•l. Subject with hypersensitivity to any of the study products.

发起方

Herbalyn Lifesciences Inc