CTRI/2022/01/039859尚未招募不适用
A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee 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 to end of trial in
研究概览
简要总结
OLNP-27 is a natural, water dispersible and highlyconcentrated boswellia extract standardized to >40% Acetyl keto- β-Boswellicacid (AKBA). It is a highly absorbable formulation produced using patentpending and clinically validated technology.
OLNP-27comprehensively resolves all the limitations of existing standard Boswelliaextracts such as lower concentration of AKBA (1 to 3%), non-dispersible, poorbioavailability, intense resinous smell (not suitable for food and beverageformats), limited applications (suitable only for capsule and tablets) and highlevels of contaminants (residual solvents, heavy metals, aflatoxins andpesticides).
This study will evaluate efficiacy of the product in OA patients
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 to 75 years of age 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 for OA treatment 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, gastrointestinal, 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 to end of trial in
时间窗: Day 0, Day 7, Day 15, Day 30, Day 60
WOMAC score
时间窗: Day 0, Day 7, Day 15, Day 30, Day 60
次要结局
- Mean Change from baseline to end of trial in(VAS)
研究者
研究点 (1)
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