A Randomized Double-Blinded Placebo-Controlled Study to Determine the Efficacy of Curcuma longa - Boswellia serrata Extract in black Sesamum indicum Seed Oil (Rhuleave-K) in Subjects with Knee Osteoarthritis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Mean change in the WOMAC total score
研究概览
简要总结
Osteoarthritis (OA), a degenerative disease that affects the joints is a leading cause of chronic musculoskeletal disability especially in the elderly populations worldwide but also affects athletes and younger individuals.OA is characterized by pain, stiffness in the morning, joint edema, restricted range of motion, diminished physical function, social activity restriction, and/or impaired work capacity. Articular cartilage and subchondral bone of synovial joints are the main targets of OA, which causes joint failure and pain during weight-bearing activities like standing and walking.In this study the investigators focus on a new formulation of turmeric (Curcuma longa) and boswellia (Boswellia serrata) extracts blended in black sesame (Sesamum indicum) seed oil using a proprietary technology.This study is a randomized double blinded placebo controlled clinical trial to determine the efficacy olf Rhuleave-K in subjects with Knee osteoarthritis. The sample size taken was 100 subjects and the treatment period is for 12 weeks. The primary outcome measure is womac.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female 40 to 70 years of age with 1:1 gender ratio.
- •NRS score greater than or equal to 5 pain intensity on walking at the time of screening BMI 18 to 29 kg/m2 Doctor diagnosed OA of knee–with Kellgren–Lawrence classification grades 1-2 Willing to give voluntary written informed consent.
排除标准
- •History of rheumatoid arthritis, severe osteoarthritis, gout, all other forms of arthritis, moderate or severe synovitis (KL grade 3 or over), meniscal rupture, fibromyalgia, underlying back pain, history of knee surgery, expectations of surgery in the next 4 months, and delayed onset of muscle soreness.
- •BMI greater than or equal to 30 High alcohol intake (greater than 2 standard drinks per day) Smoking status not more than 1 pack per day.
- •Psychotic tendencies such as schizophrenia, taking any psychotropic medicines.
- •Psychedelic or narcotic substance use Co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease or limit normal function.
- •Those who have a history of using glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronate, or systemic or intra-articular glucocorticoid within the past 3 months and during experiment period.
- •Those with a history of taking anti-inflammatory drugs, boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days, during experiment period or who have used them chronically.
- •Concomitant medications antibiotics, NSAIDS, steroids, OTC pills and ointments for pain 1 week before screening.
- •Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.
- •Positive pregnancy, breast feeding, pregnancy planning.
- •Subjects who have participated in a similar investigation in the past three months.
- •Unwilling to provide written informed consent.
结局指标
主要结局
Mean change in the WOMAC total score
时间窗: Baseline to D3, D5, D7, D42, and D84
次要结局
- Mean change in McGill(from baseline to D3, D5, D7, D42, & D84)
- Mean change in LFI(from baseline to D3, D5, D7, D42, & D84.)
- Mean change in NRS score(D1, D3, D5, D7, D42, & D84)
- Mean change in PRS score(D1, D3, D5, D7, D42, & D84.)
- Proportion of subjects using rescue medication(from baseline to D3, D5, D7, D42, & D84.)
研究者
Dr Binu T Kuruvilla
Arjuna Natural Pvt Ltd