A Randomized, Parallel group, Open label, Active controlled clinical study to evaluate the safety and efficacy of a Unani Formulation in the management of Waja al mafasil Rukba (Knee Osteoarthritis)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC–Modified CRD Pune version)
研究概览
简要总结
Osteoarthritis (Waja al mafasil) is by far the most common form of arthritis and is a major cause of pain and disability in older people. The prevalence of osteoarthritis rises strikingly with age, being uncommon in adults aged below 40 and highly prevalent in those aged more than 60.The available treatment in modern medicine, including corticosteroids, and knee replacement surgery have their limitations and adverse effects. In Unani medicine, various single and compound drugs are effectively used in the treatment of, Waja al mafasil but these drugs need to be evaluated on scientific parameters. Keeping this in view, the present clinical study has been designed to evaluate the safety and efficacy of an Unani formulation in the Management of Waja al mafasi; Rukba (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
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of any gender(male and female) in the age group of (50-70)years.
- •Participant having Knee Pain Osteophytes on Knee Radiograph, Morning Stiffness lasting upto 30 minutes and Crepitus on Active Knee Motion.
- •Body Mass Index below 40 kilogram per meter square.
- •Participants willing to sign the ICF and comply with the protocol.
排除标准
- •The following participants will be excluded from the study: Participants aged less than (50 years) and more than( 70 years) Systemic and metabolic illnesses like IHD, TB, and Malignancy.
- •Patients with Knee pain other than osteoarthritis.
- •Patients with Osteoarthritis affecting joints other than the knee joint.
- •History of Knee injury, surgery, steroid injection in knee joints Pregnancy and lactation Patients under treatment of steroids • Morbid Obesity BMI more than 40.
结局指标
主要结局
Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC–Modified CRD Pune version)
时间窗: At baseline 7th,14th,21st and 28th days
次要结局
- Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale(• Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale)
研究者
Dr Momin Sarwat Iram
National Research Institute Of Unani Medicine For Skin Disorders