Double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of C3 Reduct in patients with Joint Inflammation of the knees. - NI

Sam Sabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

研究概览

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•1. Male and Female participants whose age =18 and = 60 years.
•2. Participants should provide a written and signed informed consent and comply with requirements of the study.
•3. HsCRP level should be equal or more than 3 mg/dl.
•4. Patients with morning stiffness, painful joint movement and not on any anti-inflammatory medications.
•5. Patients with the pain perception ranging from 30 to 100 when measuring VAS (Visual Analog Scale) of 0- 100mm.
•6. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.

•1. Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infections.
•2. Patients with history of knee and hip replacement surgery.
•3. Treatment of knee joint pain with intra-articular injections of corticosteroids within last 3 months preceding study.
•4. Patients suffering from any other chronic diseases like uncontrolled diabetes, hypertension, liver disorders, cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
•5. Patients with history of asthma or on medication with Ipratropium Bromide.
•6. Patients undergoing treatment for any systemic illness.
•7. Pregnant, lactating women or women of childbearing potential and those who are not willing to follow a reliable and effective contraceptive measure during the study.
•8. History of chronic smoking and alcoholics.
•9. Those who have participated in any other clinical trial within the last 3months from the date of first visit.
•10. Any other condition/ reason which the principal investigator thinks may jeopardize the study.

发起方

Sam Sabinsa Group Limited