Clinical study to evaluate the therapeutic safety and efficacy of Habb-e-Mafasil in the management of Waja’al- Rukba (Primary Knee Osteoarthritis): An open label block randomized standard control study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1. Pain in knee joint.
研究概览
简要总结
Osteoarthritis is the most common musculoskeletal disease in the world after lower back ache. It stems from cartilage degeneration at joint sites which leads to significant pain and disability. Among all forms of arthritis, isolated knee osteoarthritis is the most common progressive multifactorial joint disease. It accounts for almost four fifths of the burden of osteoarthritis worldwide and increases with obesity and age. The global prevalence of knee osteoarthritis in individuals aged 15 and over is about 16.0% and 22.9% in individuals aged 40 and over. Correspondingly there are around 654.1 million individuals (40 years and older) with knee osteoarthritis in 2020 worldwide. In females the risk of both prevalence and incidence is higher than males. However, with ageing of the population, both the prevalence of osteoarthritis and the amount of disability associated with it have been increasing worldwide, especially in developed countries where the life expectancy has increased. Along with the pain and stiffness in joints, OA leads to joint deformities also. Despite all these complications, OA is often neglected either because it’s not a fatal disease or many physicians consider it to be a normal part of ageing and is not inherently treatable. This, however, results in vast direct medical costs and significant loss of work. It is the leading indication for total joint replacement. Presently there is no definite cure for osteoarthritis nor are there any pharmacological agents available that definitely affect the underlying pathological process. The disease is usually treated by giving Non steroidal anti-inflammatory drugs like Selective cox1 and cox2 inhibitors, corticosteroids etc that are aimed to reduce the pain and joint inflammation and hence minimize the loss of function. However the potential for serious side effects, such as gastrointestinal bleeding and ulceration, exacerbation of hypertension, and fluid retention; concerns about their renal and cardiovascular safety particularly in older individuals with co-morbidities limit their use. While in severe cases knee arthoplasty is done which is too costly with unusual eventualities. So the need of the hour is that there should be an alternative mode of treatment in order to provide safe, effective and economical treatment with least or no side effects to the patients with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •patients irrespective of gender in the age group of 20 to 65 years will be included.
- •clically and radiologically diagnosed patients with kellegren-lawrence grades 1,2 and 3 and with BMI less than 35 kg per meter square.
- •patients who have agreed to sign the informed consent form and are willing to follow up as per the study protocol.
排除标准
- •Kellgren- Lawrence grade 4 knee osteoarthritis.
- •Pregnant and Lactating women.
- •BMI more than 35kg per meter square.
- •History of recent knee infection.
- •Prior knee surgery.
- •Prior bone disease such as Osteomyelitis
- •Prior trauma to the knee joint.
- •Patients having received intra-articular knee injection as that of corticosteroids or hyaluronic acid or any investigational drug in the past one month.
- •Known cases of inflammatory joint disease as Rheumatoid Arthritis.
- •Patients with history of any significant systemic diseases like cardiovascular, gastrointestinal, renal, hepatic.
- •Patients with uncontrolled diabetes mellitus and hypertension.
- •Patients who refuse to give the written consent for the study and unwillingness to come for regular follow up as described in the study plan.
结局指标
主要结局
1. Pain in knee joint.
时间窗: At day 0, 14 and 28
2. Stiffness in knee joint after inactivity.
时间窗: At day 0, 14 and 28
3. Restriction of joint movements.
时间窗: At day 0, 14 and 28
4. Swelling either with or without effusion.
时间窗: At day 0, 14 and 28
5. Crepitus
时间窗: At day 0, 14 and 28
6. Tenderness
时间窗: At day 0, 14 and 28
次要结局
- X Ray bilateral knee joints AP and Lateral(day 0 and 28)
研究者
Zaffar Hussain
Regional Research Institute Of Unani Medicine (RRIUM) Srinagar
