A randomized double-blinded placebo-controlled study to determine the efficacy of Turmeric extract (BCM-95) with mild to moderate osteoarthritis.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Difference in the WOMAC recommended index of joint pain
研究概览
简要总结
Osteoarthritis (OA), a degenerative age-related disease that affects the joints, is the most common human musculoskeletal disorder and a leading cause of disability in elderly populations worldwide. The symptoms of OA include pain, morning stiffness, joint swelling, limited range of motion, decreased physical function, restriction of social activities and/or compromised work capacity. OA primarily affects articular cartilage and subchondral bone of synovial joints and results in joint failure, leading to pain with weight-bearing activities including walking and standing. Current OA treatments rely on analgesics, NSAIDs and cortisone, which manage pain and inflammation but have a wide range of adverse effects, drug interactions and contraindications and fail to restore the imbalances between catabolic and anabolic processes that underlie OA pathogenesis. This study aims to evaluate the efficacy of 200 mg of turmeric extract (BCM-95) can deliver clinically meaningful pain relief and functional improvement while maintaining a favorable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female 18 to 70 years of age with 1:1 ratio.
- •NRS score of ≥ 5 pain at the time of screening.
- •BMI 18 to 29kg/m
- •WOMAC score for Pain.
- •2 or more for any two activities. Stiffness – 1 or more for any one activity. Physical function – sub-score 10 or more.
- •Doctor diagnosed OA of knee –with Kellgren–Lawrence classification grades 2-
- •Ability to follow all instructions in the study protocol and be willing to give written informed consent.
排除标准
- •History of any underlying back pain, inflammatory arthropathy, rheumatoid arthritis, severe osteoarthritis, fibromyalgia, gout or knee surgery within the past 6 months.
- •Additionally, include any anticipated surgeries in the next 4 months and details of any hyaluronic acid treatments, either alone or in combination with Intra-articular corticosteroid injections received within the past 3 months.
- •Alcohol dependence
- •Smoking status more than 1 pack cigarettes 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 in the judgment of the investigator.
- •History of the use ointments used for pain within the past 2 weeks, any antibiotics, NSAIDs, steroids, over-the-counter pills as well as any supplements taken for joint pain three months prior to your 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
Difference in the WOMAC recommended index of joint pain
时间窗: Baseline, Week 6, Week 12
次要结局
- To assess OARSI performance-based tests(Baseline, Week 6, Week 12)
- Change in NRS score(Baseline, Week 6, Week 12)
- Change in anti-inflammatory and antioxidant biomarkers(Baseline, Week 6, Week 12)
- To assess the safety by blood biochemistry, vitals(Baseline, Week 12)
研究者
Dr Binu T Kuruvilla
Arjuna Natural Private Limited