A Randomized, Double Blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients with Painful knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- •Changes in the arthritis impact measurement scale (AIMS 2)
研究概览
简要总结
| ARandomized, Double Blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES inPatientswithPainful knee Osteoarthritis. |
| Primary objectives: To show that the efficacy of EASY CLIMB CAPSULES inPatients withPainful Knee Osteoarthritis. |
**Secondary objectives:**To evaluate the safety of EASY CLIMB CAPSULESinPatients withPainful Knee Osteoarthritis
Primary outcomes
- Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)]
- Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score
- WOMAC Osteoarthritis Composite Index & QOL
- Changes in the arthritis impact measurement scale (AIMS 2)
- Change from Baseline in the CGI (Clinical Global Impression) scale score
- Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis.
Secondary outcomes
- Safety assessed byAdverse 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Men and women with age of 40 – 65 with a diagnosis of arthritis.
- •â€¢Obtaining written Inform consent along with audio, video visual.
- •â€¢Patients with mild to moderate arthritis •Participants who are able to visit the medical institutions throughout the study period.
排除标准
- •â€¢Patients with Uncontrolled hypertension or diabetes.
- •â€¢Patients with Hepatic or renal impairment •Patients with Current or expected use of anticoagulant •Candidates for imminent joint replacement •Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months •Participation within 30 days prior to screening in another investigational study •Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
- •â€¢Any contraindication to blood sampling.
- •â€¢HIV Positive serology •Pregnant (or) Lactating.
结局指标
主要结局
•Changes in the arthritis impact measurement scale (AIMS 2)
时间窗: •Screening to EOT (Day 120)
•Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)]
时间窗: •Screening to EOT (Day 120)
•Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score
时间窗: •Screening to EOT (Day 120)
•Change from Baseline in the CGI (Clinical Global Impression) scale score
时间窗: •Screening to EOT (Day 120)
•WOMAC Osteoarthritis Composite Index & QOL
时间窗: •Screening to EOT (Day 120)
•Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis.
时间窗: •Screening to EOT (Day 120)
次要结局
- Safety assessed by Adverse Events(Screening to EOT (Day 120))