A randomized, double-blind, parallel-group, comparative, multicenter, placebo-controlled clinical trial to assess the efficacy & safety of nutritional formulations in the management of knee osteoarthritis. - NI

ife Synergy0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1.Patients of either sex with age 40 to 65 years (both inclusive) with a BMI not more than 30.00 kg/m2; 2.Confirmed diagnosis of knee osteoarthritis as per clinical American College of Rheumatology (ACR) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age greater than 50 years, morning stiffness less than 30 min, crepitus, bony tenderness, bony enlargement, and no palpable warmth; 3.Patients with a minimum pain visual analog scale (VAS) score greater than 4 on walking in one or both knees during the 24 hrs. preceding recruitment; 4.Patient ambulant and requiring treatment with an anti ?inflammatory drug and not receiving regular anti ?inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change; 5.Patients taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention. 6.Patients willing to come for regular follow up visits; 7.Participants can walk and give both verbal and written information regarding the study.

•1.Known history of hypersensitivity to herbal extracts or dietary supplements;
•2.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test;
•3.Non-degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection);
•4.Patients incapacitated or bound to a wheelchair or bed and unable to carry out self-care activities;
•5.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;
•6.Evidence of several renal, hepatic, or hematopoietic diseases or severe cardiac insufficiency as revealed by laboratory investigations;
•7.Patient with congestive heart failure;
•8.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 3 months;
•9.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;
•10.Indication of surgery for OA knee;
•11.Arthroscopy of either knee in the past year;
•12.Any condition that in the opinion of the investigator does not justify the patient’s inclusion in the study.

发起方

ife Synergy