Efficacy of a Topical Pain formulation in participants suffering from Osteoarthritis of Knee(s) - A randomized, double blind, placebo controlled, multi-centric, comparative, prospective study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- 1. Change in knee joint pain on Visual Analogue Scale
研究概览
简要总结
It is a randomized, double blind, placebo controlled, multi-centric, comparative, prospective clinical study to evaluate efficacy of a Topical Pain formulation in participants suffering from Osteoarthritis of Knee(s). The study will be carried out at 6 to 7 sites in India. As per computer generated randomization list, participants will be randomized either to Topical Pain formulation group or placebo formulation group. Participants will be asked to apply a thin layer of given mediation onto the skin of the affected area of knee joint, 3 times daily for 28 days. The primary objectives of the study will be to assess change in knee joint pain on Visual Analogue Scale and change in joint swelling (inflammation) using knee joint girth measurements. The secondary objectives of the study will be to assess change in pain, stiffness and physical function using graded scale, change in knee joint tenderness and warmness on graded scale, time of onset of action (as pain reliever) after application in min/hrs, duration of action (as pain reliever) after application in min/hours, global Assessment for overall change in OA by subject and investigator on baseline visit, visit 1 (Day 14) and visit 2 (Day 28)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of knee pain due to Osteoarthritis
- •Knee joint(s) pain between 30 to 70 on Visual Analogue Scale (VAS) (both inclusive) (mild to moderate pain).
排除标准
- •Known chronic severe (more than four years) cases of OA and having developed any kind of joint deformity.
- •Known cases of rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis other than OA, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
- •Participants with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
- •Participants requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
- •Participants using systemic corticosteroids within 1 month of screening,
- •Intra articular visco supplementation within the past 3 months
- •Participants with any other investigational drug within 1 month prior to randomization;
- •Participants with uncontrolled diabetes mellitus and hypertension
- •Pregnant and lactating women
- •Known hypersensitivity to any of the ingredients of Study drugs or to NSAIDs
- •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his her participation in, and completion of the protocol.
结局指标
主要结局
1. Change in knee joint pain on Visual Analogue Scale
时间窗: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)
2. Change in joint swelling (inflammation) using knee joint girth
时间窗: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)
measurements
时间窗: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)
次要结局
- 1. Change in pain, stiffness and physical function using graded scale(2. Change in knee joint tenderness and warmness on graded scale)
研究者
Dr Kuldip Raj Kohli
Kohli’s Ayurveda and Panchakarma Centre (KAPC)