Randomized, double blind, placebo controlled clinical study to assess the efficacy & safety of Re-Cart capsules in subjects with knee osteoarthritis. - NI

Cachet Pharmaceuticals Pvt.Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•1.Adults (age 18 to 60) both sex with BMI not more than 30.00 kg/m2;
•2.Confirmed Diagnosis of knee osteoarthritis as per ACR (American College of Rheumatology)
•3.Patient reported pain score between 5-15 (Both inclusive) on WOMAC-A scale at screening.

•1.Conditions such as rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudo gout or pain due to malignant disease as per clinical judgement or available evidences and laboratory findings with patients;
•2.BMI >30 kg/m2;
•3.Indication of surgery for OA knee;
•4.Arthroscopy of either knee in the past year;
•5.Use of systemic steroids or herbal medication for OA within 4 weeks of screening;
•6.Use of Vit. D3 injections, Glucosamine sulphate, Chondroitin sulphate, Diacerin, Alendronate in the past 3 months;
•7.Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months;
•8.History of osteoporotic/ osteoarthritic fractures within the past 6 months;
•9.Pregnant or lactating women or women with inadequate contraceptive measures;
•10.Evidence or clinical suspicion of any major medical conditions (E.g. uncontrolled diabetes mellitus, uncontrolled hypertension, cardiovascular disease, thyroid, hepatic, renal dysfunction);
•11.Presence of any clinically significant laboratory anomaly;
•12.Moderate to severe peripheral neuropathy or other neurological disorders;
•13.Alcohol abuse, medication or drug dependence.

发起方

Cachet Pharmaceuticals Pvt.Ltd