A Randomized Double Blind Double Dummy Placebo Controlled Parallel Group Study to Evaluate the Safety and Efficacy of OLNP 08versus placebo in Reducing Symptoms of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean Change from baseline in WOMAC Score
研究概览
简要总结
OLNP-08 is a unique andnovel formulation of natural active ingredient, curcuminoids, which is found topossess significant anti-inflammatory and anti-oxidant activity. OLNP-08 uses aunique technique for the solubilisation of curcuminoids, the major active ingredient to yield anemulsified formulation which is found to have higher bioavailability and easytransport across the cell membrane.Curcuminoids belongs to a group of flavonoids which are known to exhibit significantanti-inflammatory and anti-oxidant activity with inhibitory effect on many cytokines like TNF-α, IL-1β, IL-6 etc. Several invivo studies have demonstrated amarked inhibition of inflammatory mediators in animals treated with curcumin and thereby suggesting its role in reducing the inflammatory symptoms associated with Osteo arthritis.
It is A Randomized, Double Blind,Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy ofOLNP-08 versus placebo in Reducing Symptoms of Knee Osteoarthritis.
Totally 66 number of subjects planned to randomized into on of the three arm in 1:1:1 ratio. the total treatment period will be 60 days. A total 66 subjects planned to be randomized in each group only after satisfying all inclusion and exclusion criteria. Patients are requested to visit on next day after screening date (Day 0), Day 07, Day 15, Day 30, and Day 60. The efficacy will be calculated by WOMC, VAS, LFI to and Primary knee flexion from baseline to end of the study.
The purpose of this study is designed to assess the clinical effectiveness and safety of OLNP-08 vs. placebo in reducing the Osteoarthritis symptoms of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory, Male and female subjects 40 – 75 years 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 (ACR criteria) 3.Subjects with radio graphic evidence by Kellgren.
- •Lawrence grade 2 or 3
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control. 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
- •Results of screening are within normal range or considered not clinically significant by the Principal Investigator
- •Be 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.
- •Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication
- •History of underlying inflammatory arthropathy or severe RA or OA
- •Subjects scheduled for any surgery within 3 months of completing the study
- •Recent injury in the area affected by OA of the knee (past 4 months)
- •History of Gout
- •History 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
- •History of Systemic Lupus Erythematosus (SLE) 10.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc)
- •History 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
Mean Change from baseline in WOMAC Score
时间窗: Day 0, Day 7, Day 15, Day 30, day 60
次要结局
- Change from baseline in(•Visual Analog Scale &)