A parallel arm clinical study to evaluate the efficacy and safety of pain relief oils in patients with osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. WOMAC A, B, and C subscale scores for pain, stiffness and physical disability. WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and WOMAC-C for levels of physical disability
研究概览
简要总结
Pain relief oils are commonly used in the management of osteoarthritis (OA) to alleviate pain and reduce inflammation. These oils often contain natural ingredients with anti-inflammatory and analgesic properties. When applied topically, they provide relief by promoting circulation, reducing muscle stiffness, and soothing joint discomfort. This oils, may also stimulate nerve endings, reducing pain perception. While effective for mild to moderate pain, they are typically used as part of a broader pain management plan in osteoarthritis treatment.
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
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants meeting all the following criteria will be eligible for the study:
- •Adults aged 45 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg per meter square;
- •Clinical diagnosis of osteoarthritis of the knee based on clinical evaluation and or radiographic evidence;
- •Participants with a pain visual analog scale (VAS) score between 1-7 (mild-moderate) preceding recruitment;
- •Participant ambulant and requiring treatment with an anti inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change;
- •Participants willing to come for regular follow up visits and provide data of the analgesic consumption during study period;
- •Participants can walk and give both verbal and written information regarding the study.
排除标准
- •Participants meeting any of the following criteria will not be eligible for the study:
- •Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities;
- •Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study;
- •Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine;
- •Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months;
- •Indication of surgery for OA knee;
- •Arthroscopy of either knee in the past year;
- •Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study.
结局指标
主要结局
1. WOMAC A, B, and C subscale scores for pain, stiffness and physical disability. WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and WOMAC-C for levels of physical disability
时间窗: 1. Baseline, day 15, 30, day 60 | 2. Screening, baseline, day 15, 30, day 60 | 3. Screening and day 60 | 4. Baseline, day 15, 30, day 60
2. VAS pain scale score
时间窗: 1. Baseline, day 15, 30, day 60 | 2. Screening, baseline, day 15, 30, day 60 | 3. Screening and day 60 | 4. Baseline, day 15, 30, day 60
3. Knee range of motion (ROM) measured by goniometer
时间窗: 1. Baseline, day 15, 30, day 60 | 2. Screening, baseline, day 15, 30, day 60 | 3. Screening and day 60 | 4. Baseline, day 15, 30, day 60
4. Symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmth
时间窗: 1. Baseline, day 15, 30, day 60 | 2. Screening, baseline, day 15, 30, day 60 | 3. Screening and day 60 | 4. Baseline, day 15, 30, day 60
次要结局
- 1. Adverse events profile(2. Tolerability of the investigational product)
研究者
Dr Amol Gothwad
Lokmanya Medical Research Centre and Hospital