CTRI/2024/05/068001招募中2 期
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. - NI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
研究者
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