A Randomized, Double Blind, Placebo Controlled, Three Treatment, Parallel Group Study to Evaluate the Safety and Efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients with Osteoarthritis of Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- 1. Change in Pain Visual Analogue Scale (VAS) [100 mm].
研究概览
简要总结
Osteoarthritis is a degenerative disease of the joint affecting aging populations worldwide. It has an underlying inflammatory cause, which contributes to the loss of chondrocytes, leading to diminished cartilage layer at the affected joints.The study is a Randomized, Double Blind, Placebo Controlled, Three Treatment, Parallel Group Study to Evaluate the Safety and Efficacy of Maxicuma® 100 Capsules and Maxicuma® 250 Capsules in patients with Osteoarthritis of Knee. The product curcumin possesses both anti-inflammatory and antioxidative activities. The anti-inflammatory effect of the curcumin is also realized through its potential to inhibit the production of inflammatory and catabolic mediators by chondrocytes4. Maxicuma® Capsules are nutraceutical supplements with turmeric extracts rich in curcumin which is one of the potential anti-osteoarthritic agents under limelight. All the modulatory effects exerted by curcumin could be salvaged to provide an efficient therapeutic option in the management of osteoarthritis of knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects 45-65 years (both inclusive) of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m
- •Unilateral or bilateral OA of the knee for greater than 3 months (NICE criteria) Note: According to the criteria from NICE, patients can be diagnosed with knee OA if they are 45 years or older, have movement-related joint pain and either no morning knee joint related stiffness or stiffness of 30 min or less.
- •Subjects with radiographic evidence by Kellgren.
- •Lawrence grade 2 or 3
- •Female subjects of childbearing potential must be using a medically acceptable and reliable form of birth control. (Hormonal pills and intra-uterine devices are not considered as a reliable method of contraception). Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
- •VAS score during the most painful knee movement between 40-70 mm
- •Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs.
- •Screening parameters are within normal range or considered not clinically significant by the Principal Investigator
- •Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application (OTC or prescription) and Omega 3 fatty acids during the entire trial.
- •Willing to sign the informed consent and comply with study procedure.
排除标准
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •Subjects with radiographic evidence by Kellgren.
- •Lawrence grade
- •Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
- •Patients who are allergic or hypersensitive to turmeric or turmeric supplements.
- •History or presence of underlying inflammatory arthropathy, RA, severe OA, gout, Systemic Lupus Erythematosus (SLE), any disorders related to bleeding/clotting or any other systemic disorder affecting joints.
- •Subjects scheduled for surgery within 3 months of completing the study.
- •Recent injury in the area affected by OA of the knee (past 4 months)
- •History or presence of congestive heart failure.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- •High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)
- •History or presence of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
- •Have taken any corticosteroid, indomethacin, Glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period.
结局指标
主要结局
1. Change in Pain Visual Analogue Scale (VAS) [100 mm].
时间窗: Timepoints: Baseline- Prior Randomization, End of Study- Day 90
2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores.
时间窗: Timepoints: Baseline- Prior Randomization, End of Study- Day 90
次要结局
- 1. Change in Pain Visual Analogue Scale (VAS) [100 mm].(2. Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) domain scores.)