A Randomized, Double Blind, Placebo Controlled,Parallel-Group Study to Evaluate the Safety and Efficacyof OLNP-08 versus placebo in Reducing Symptoms ofKnee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Change from baseline in WOMAC score
研究概览
简要总结
Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder, which commonly affects the knee joint. Osteoarthritis disables about 10% of people who are older than 60 years, compromises the quality of life of more than 20 million Americans, and costs the United States economy more than $60 billion per year.
OLNP-08 is a unique and novel formulation of natural active ingredient, which is found to possess significant anti-inflammatory and anti-oxidant activity. So this randomized, double blind, placebo control, parallel group study is designed to access the efficacy and safety of OLNP-08 capsule versus placebo for the treatment of Osteoarthritis. A total 50 subjects will be randomized with 1:1 allocation for test group (OLNP-08) and for control group (Placebo) for a period of approximately 60 days. During the study, subjects will visit the study site at screening visit (Day -7 to 0) randomization visit (Day 1), visit 2 (Day 7), visit 3 (Day 15), visit 5 (Day 30) and at final visit (Day 60).
The efficacy will be accessed on the basis of WOMAC score and VAS score. Safety parameters will be evaluated on basis of change in vitals, Laboratory parameters and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •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
- •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.
- •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, ngastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies
- •History of Systemic Lupus Erythematosus (SLE)
- •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 30days 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: Screening visit (Day 07 to 0), Randomization | visit (Day 1), Visit 2 (Day 7), Visit 3 (day 15), | Visit 4 (Day 30) and Visit 5 (Day 60)
次要结局
- Change from baseline in Visual Analog Scale((VAS))
- Change from baseline in WOMAC subscale(score (pain, stiffness and physical function))