A Clinical study on the Efficacy of Karaskara Ghritam (Orally) and Agni Karma (Bindu Akruti) in the management of Janusandhigata Vata W.S.R to Osteo Arthritis - Knee
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To provide relief from the clinical features of Janusandhigata Vata - Osteo Arthritis Knee.
研究概览
简要总结
v Janu Sandhigata vata is the most common form of the Sandhi (joint) disorders. It is commonly known as degenerative joint disease or “wear and tear†arthritis. It occurs most frequently in the knees, hips and hands.
v With Osteo Arthritis, the cartilage within a joint begins to break down and the underlying bone begins to change. These changes usually develop slowly and get worsen over a period of time. Osteo Arthritis can cause pain, stiffness and swelling. In some cases, it also causes reduced function and disability; some people are no longer able to attend their daily tasks or work.
v In the present era, human beings are prone to early degenerative diseases, because of stressful and sedentary life style habits.
v According to WHO, Osteo Arthritis is the second commonest musculoskeletal problem in the world population.
v The following are the risk factors of Osteo Arthritis :
Ø Joint injury or overuse – Injury or overuse, such as knee bending and repetitive stress on a joint, can damage a joint and increase the risk of Osteo Arthritis in that joint.
Ø Age – The risk of developing Osteo Arthritis increases with age.
Ø Gender – Women are more likely to develop Osteo Arthritis than men, especially after the age of 50.
Ø Obesity – Extra weight puts more stress on joints, particularly weight-bearing joints like the knees and hips. This stress increases the risk of Osteo Arthritis in that joint. Obesity may also have metabolic effects that increase the risk of Osteo Arthritis.
Ø Genetics – People who have family members with Osteo Arthritis are more likely to develop Osteo Arthritis. People who have hand Osteo Arthritis are more likely to develop knee Osteo Arthritis.
Ø Race – Some Asian populations have lower risk for Osteo Arthritis.
v Osteo Arthritis was the 20th most common cause of Years Lived with Disabilities in India in 2019, accounting for 1.48% of all Years Lived with Disabilities; increasing from 23rd most common cause in 1990 (1.25%).
v Over the last three decades, the prevalent symptomatic Osteo Arthritis cases in India increased 2.66-fold from 23.46 million in 1990 to 62.35 million in 2019.
v Total Disability Adjusted Life Years due to Osteo Arthritis increased by more than 2.69-fold, from 0.79 million (95%) UI: 0.40–1.55) in 1990 to 2.12 million (95% UI: 1.07–4.23) in 2019.
v The prevalence, incidence, and Disability Adjusted Life Years for Knee Osteo Arthritis are consistently higher in females than males.
v In the present era, human beings are prone to early degenerative diseases, because of stressful and sedentary life style habits.
v A number of drugs which are effective in relieving symptoms are available in contemporary sciences. But, in due course these drugs can cause adverse effects when used for a long time, causing an additional trouble for the patients.
v Keeping this in view, it is needed to focus on drugs which are of herbal sources and cost effective.
v Hence, the drug selected for this study in Janu Sandhigata vata is Karaskara Ghrita. The drug possess Vata Pitta Shamaka, Vedana Sthapana, Anulomana, Shothahara, Rasayana, Sula Prashamana properties and the selected procedure – Agnikarma acts on Vata Kapha dosha and alleviates the pain. Pain reduces significantly with minimal recurrence rates.
Considering all the above points, a treatment modality focusing on Ayurvedic approach in the management of Janu Sandhigata vata using the Vatahara drugs has been formulated, which is essential for its effective management in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having symptoms of Janu Sandhigata Vata like Sandhi Shotha, Vatapurna drithi Sparsha, Akunchana Prasarana vedana.
- •Patients with classical signs and symptoms of Sandhigata vata will be selected; irrespective of religion, profession, etc.
- •Patients with clinical features of Osteo Arthritis and radiological findings of Osteo Arthritis in the Knee joints.
- •Radiological changes as per grades 1 to 3 of Kellgren-Lawrence radiological scale of Osteo Arthritis.
- •Patients who are not responding by a single therapy.
- •Patients who are eligible and who give informed consent to undergo Agni karma.
排除标准
- •Sandhigata vata other than Janu sandhigata vata.
- •Patients with other connective tissue disorders and secondary Osteo Arthritis.
- •Patients with congenital, physical deformity of knee joint and any history of trauma.
- •Patients with co-morbidities such as Gouty Arthritis, Rheumatoid Arthritis, Psoriatic Arthritis, etc.
- •Patients who are currently participating in any other Clinical trials.
- •Meniscal tear and ligament injury.
- •Patients with uncontrolled Diabetes.
- •Patients with Obesity (BMI >30), HIV, HbsAg, uncontrolled Hypertension, Hyperlipidemia, Cancer, Left Ventricular Hypertrophy, Ishchaemic Heart Disease, Tuberculosis and other systemic disorders which may lead to fatal condition.
- •Pregnant women and Lactating mothers.
- •Post Knee Replacement surgery.
- •4th grade of Kellgren – Lawrence grading Scale Classification.
- •Patients who are contraindicated to undergo Agni karma.
结局指标
主要结局
To provide relief from the clinical features of Janusandhigata Vata - Osteo Arthritis Knee.
时间窗: 60 days
次要结局
- To restore the normal Range of Motions.(60 days)
研究者
Dr V Kranthi Kumari
Dr BRKR Government Ayurvedic Medical College, Erragadda, Hyderabad
