CTRI/2021/10/037470尚未招募2/3 期
A parallel arm interventional Clinical Study to Assess the Efficacy and Tolerability of a AVI- TR 01 ointment in Patients with chronic osteoarthritis of knee and low back ache.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in severity of other symptoms like swelling, tenderness
研究概览
简要总结
The present study is to clinically validate the effectiveness of AVI- TR 01 ointment in subjects suffering from osteoarthritis of knee and low back ache
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged 30 to 65 years Patients with back pain for at least 3-6 months with score on VAS more than or equal to 4 Patients with Knee pain for at least 3-6 months with score on VAS more than or equal to 4 Suffering from joint discomfort for at least 3 months duration Subjects agreeing to discontinue any use of analgesics during the study.
- •Ready to provide written informed consent Willing to come for the follow-up visits for evaluation.
排除标准
- •Surgery for low back pain/ knee joint pain in the last 6 months or planning for surgical intervention during the course of the study.
- •Sensitive skin and damaged/ broken skin at the application site.
- •Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Paget’s disease, hemophilia etc.
- •Presence of any severe medical or psychological condition Patients participated in another clinical drug trial within 3 months before recruitment in this trial Any other medical condition that in the Investigators opinion would preclude patient participation Subjects with past history of addiction abuse and rehabilitation.
结局指标
主要结局
Changes in severity of other symptoms like swelling, tenderness
时间窗: Baseline, Day 7 and Day 14
Changes in pain score with VAS
时间窗: Baseline, Day 7 and Day 14
Changes in WOMAC score
时间窗: Baseline, Day 7 and Day 14
次要结局
- Assessment of quality of life (QoL)(Changes in in requirement of analgesics as a rescue medication)
研究者
研究点 (1)
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