CTRI/2021/07/034559进行中（未招募）不适用
A prospective, observational, real world evidence study to assess effectiveness & safety of HAPID® (Un-denatured Type II Collagen 40 mg and Aflapin 100 mg) of Wockhardt Limited in the management of patients with Knee Osteoarthritis
Wockhardt Ltd1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年5月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1. Change in Mean overall WOMAC score
研究概览
简要总结
This is a prospective, observational, real world evidence study toassess effectiveness and safety of HAPID® (Un-denatured Type II Collagen and Aflapin) of Wockhardt Limited inthe management of patients with Knee Osteoarthritis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Ambulatory adult patient, clinically or radiologically confirmed diagnosis of Knee Osteoarthritis newly prescribed with HAPID® (Un-denatured Type II Collagen and Aflapin), willing to provide written informed consent and comply to the study as per protocol.
排除标准
- •1.History or evidence of hypersensitivity to any component of study medication 2.History of viscosupplementation within 9 months prior to date of screening 3.History of allergy to eggs or chicken 4.Pregnant or lactating women 5.Any other reason which in opinion of investigator preludes participation in study.
结局指标
主要结局
1. Change in Mean overall WOMAC score
时间窗: Day 1, Day 5, Day 30, Day 60 and Day 90.
2. Change in Mean VAS score
时间窗: Day 1, Day 5, Day 30, Day 60 and Day 90.
3. Change in Mean WOMAC subscales
时间窗: Day 1, Day 5, Day 30, Day 60 and Day 90.
次要结局
- Incidence of Adverse Events, during treatment with HAPID®(Day 1, Day 5, Day 30, Day 60 and Day 90.)
研究者
研究点 (1)
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