Efficacy of Rasnadi Guggulu with Maharasnadi Kwatha in Knee Osteoarthritis - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary outcome will be VAS and WOMAC Scale in Knee osteoarthritis in 60 days.
研究概览
简要总结
Osteoarthritis is the most common form of Arthritis and is a major cause of pain and disability in older people, affecting an estimated 302 million people Worldwide. The prevalence of Knee OA is more in India, Japan, China and African subcontinent. The prevalence rises progressively with age and is the most common joint disease with the prevalence of 22% to 39% in India.
In this degenerative condition there will be pain, swelling and the movement of the joint is restricted. Thus, palliative management NSAIDs and Opioids are the mainstays of pharmacotherapy, even Knee Replacement is another option in managing Osteoarthritis. But all of these have some limitations with various adverse effects. Moreover, there are no proven disease-modifying therapies for osteoarthritis. Thus, Preventive measures previously addressed need to be reaffirmed throughout the world so that we will effectively reduce the future burden and disability of OA.
Previous Ayurveda studies such as Panchakarma therapies and Shaman Aushadhi’s have shown some good results. For reducing pain, stiffness and inflammation Rasna is one of the best choices having such properties to combat this condition. Thus, Rasnadi Gugguluand Maharasnadi Kwathaare taken up for the study to see the effect on symptoms, Quality of life and IL-6 in knee osteoarthritis. Also, Considering the chronicity of the disease, a long-term safe and efficacious medication is required for the management. Thus, it is an attempt to see the effect of medication on Knee Osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Individuals aged between 40 years to 70 years 2 Subjects with Signs and Symptoms of Sandhigatavata as per Ayurvedic classics 3 Subjects fulfilling the diagnostic criteria & diagnosed previously (As per American college of Rheumatology (ACR) classification criteria for OA of the Knee) 4 Affected knee joint.
- •Single or Both 5 Pain in the knee joints greater than or equal to 3 months 6 Patients of Either Sex.
排除标准
- •1 Patients with Severe arthritis (KL grade IV) 2 Gross disability like bedridden and confined to wheel chair 3 Patients with RA, Gout, Osteoporosis and other Musculoskeletal system disorders 4 Patients with other major systematic disorders which interfere with the treatment will be excluded like uncontrolled DM (FBS>130 mg/dL, PPBS> 250 mg/dL, HbA1C> 8.5%) and Hypertension> 160/100 mm of Hg 5 Patients with ligamental or any other knee joint injury 6 Patients with history of Knee surgery 7 Use of NSAIDs, Analgesics, Intra articular steroid injections within the past period of 30 days.
- •8 Pregnant or lactating women.
结局指标
主要结局
Primary outcome will be VAS and WOMAC Scale in Knee osteoarthritis in 60 days.
时间窗: Baseline, 15th, 30th, 45th and 60th day
次要结局
- Secondary Outcome of Knee Osteoarthritis on the basis of WHOQOL-BREF Scale, Goniometry of Knee Joint, Walking Velocity & Interleukin-6 (IL-6)(WHOQOL-BREF Scale – On Baseline, 15th, 30th, 45th, & 60th day)