Comparative Clinical Study To Evaluate The Efficacy Of Shothaghna Lepa And Shothaghna Transdermal Patch In The Management Of Sandhigata Vata (Sama Avastha)- A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This study is a randomized, open-label, two-arm comparative clinical trial to evaluate the efficacy of classical Shothaghna Lepa versus Shothaghna Transdermal Patch in the management of Sandhigatavata. A total of 30 patients (15 in each group) diagnosed with Sandhigatavata will be recruited from OPD/IPD and randomly allocated to receive either daily application of classical Shothaghna Lepa or a standardized Shothaghna transdermal patch for 7 days, with follow-up on Day 14. The primary outcome will be reduction in joint swelling (Sandhishotha), while secondary outcomes include improvement in pain, stiffness, patient compliance, and safety. The study aims to compare the clinical effectiveness and usability of a traditional Ayurvedic Lepa with a patient-friendly transdermal patch formulation to provide a more convenient and effective external therapy for inflammatory joint conditions.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fulfilling the signs and symptoms of samsandhigatvata Vata Patient of all socio-economic group.
- •Patient who is willing to give written consent.
排除标准
- •Patient having known allergic reactions to the components of the Shothaghna Lepa.
- •Patient having other joint diseases like Psoriatic Arthritis, Gout Arthritis and Rheumatoid Arthritis.
- •Patient with Pregnancy and lactating women.
研究者
Dr Deependra Karnawat
Parul Institute of Ayurved and Research