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.

Life Synergy1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2024年7月15日最近更新: 2024年7月10日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 90
试验地点: 1
主要终点: 1.Changes in WOMAC A, B, and C subscale scores for pain, stiffness, and physical disability

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

OA is a highly prevalent chronic joint disease that leads to significant pain, disability, and loss of function, particularly in the knees. Pharmacological treatments for OA primarily focus on symptom relief and often come with adverse effects, such as gastrointestinal and cardiovascular issues. There is a growing need for safer, more effective treatments that not only alleviate symptoms but also address the underlying pathophysiology of OA.

This study aims to fill this gap by evaluating the effects of nutritional formulation on pain, stiffness, and mobility in participants with knee OA over 90 days.

The studyâ€™s design includes comprehensive assessments of both primary and secondary endpoints. These include changes in WOMAC scores, VAS pain scale, six-minute walk test, inflammatory biomarkers, and reliance on analgesics. Additionally, safety will be rigorously monitored through adverse event profiling and hematological and biochemical evaluations.

The results could offer a new, nutritional option for OA patients, potentially improving their quality of life while minimizing the risks associated with conventional treatments.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 40.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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 â€“ 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 antiâ€inflammatory drug and not receiving regular antiâ€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.

排除标准

•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 patientâ€™s inclusion in the study.