A Multimodal Ayurvedic Intervention In The Management Of Primary Osteoarthritis Of Knee - A Single Arm Clinical Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Pain in knee joint, Swelling on knee joint, Stiffness, Pain during flexion and extension, Crepitus, Degenerative changes of Primary osteoarthritis.
研究概览
简要总结
Primary Osteoarthritis is most common joint degenerative disease restricting day to day activity of patients due to pain. Treatment provides only symptomatic relief that is for limited duration. This study includes the treatment method from classical Ayurvedic texts. Who are suffering from cardinal and associated symptoms of Primary osteoarthritis satisfying the inclusion & exclusion criteria are selected for the study. The selected subjects are given Hingwastak Churna 5 gm twice a day First morsel of meals with Goghrita for 3 days, followed by incremental administration of Ashwagandha ghrita for 5/7 days(60ml-80ml-100ml-120ml-140ml). After getting Samyaka Snigdha lakshana, Abhyang and Swedana are performed using Nirgundi taila and Baspa sweda, respectively for 8 days and Yoga Basti conducted with Anuvasana basti with Ashwagandha ghrita 120ml/dose and Niruhbasti with Erandmooladi niruh Madhu-160 ml, Lavana-12 gm, Sneha-240 ml, Kalka-80 gm, Kwath-320 ml, Gomutra-160 ml dose adjust according to patient. As per Shuddhi Samsarjan krama provided. Then Rasayana chikitsa with Ashwagandha churna10gm in morning with Godugdha and Triphala churna 10gm at night with warm water is given for 2 month. Total duration of study is 3 months.
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
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with classical signs & symptoms of Primary Osteoarthritis of knee.
- •Patient having Nirupstambhi Sandhigatavata Lakshana.
- •Patient’s grade 1 to 3 according Kellgren-Lawrence grading scale will be taken for study.
- •Snehapana, Asthapana and Anuvasana Basti yogya patient.
- •Patients willing to participate in clinical trial.
排除标准
- •Patient having Upstambhi Sandhigatavata Lakshana.
- •Patients grade 4 according Kellgren-Lawrence grading scale will be excluded for the study.
- •Snehapana, Asthapana and Anuvasana Basti ayogya patient.
- •Patients with uncontrolled Diabetes mellitus and Hypertension, known case of Heart disease, Kidney disease, Stroke, Liver disease, Pulmonary dysfunction or COPD systemic illness like Rheumatoid arthritis, Gout, Systemic lupus erythematosus, Tuberculosis, AIDS and SIDS etc.
- •which interferes the clinical trial.
- •Patients taking medications like NSAIDs, Corticosteroids, Hormonal therapy, Anti depressants or any other drugs which may affect outcome of the study.
- •Patients with alcohol and tobacco addiction or drug abuse.
结局指标
主要结局
Improvement in Pain in knee joint, Swelling on knee joint, Stiffness, Pain during flexion and extension, Crepitus, Degenerative changes of Primary osteoarthritis.
时间窗: 4 Weeks
次要结局
- Improvement in life quality of patient.(Within 3 months.)
研究者
Dr Komal Sureshbhai Prajapati
G. J. Patel Institute of Ayurvedic Studies and Research