An open label randomised control clinical study to assess the effectiveness of Rasna Panchaka Ghana Vati and Trayodashanga Guggulu in the management of pain in Janu Sandhigata Vata (Osteoarthiritis of Knee) after kosthashodhana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
Janu Sandhigata Vata, comparable to osteoarthritis of the knee, is a common degenerative joint disorder characterized by pain, stiffness, swelling, and restricted movements, especially affecting the elderly population. Conventional management mainly focuses on symptomatic relief using NSAIDs and physiotherapy, which may be associated with adverse effects and limited long-term benefits. Ayurveda offers a holistic approach through Shodhana and Shamana therapies for managing such chronic conditions.
This study is an open-label, randomized, controlled clinical trial designed to evaluate and compare the effectiveness of Rasna Panchaka Ghana Vati and Trayodashanga Guggulu in the management of pain in Janu Sandhigata Vata (osteoarthritis of knee) following Koshthashodhana. A total of 140 patients will be randomly allocated into two groups of 70 each. Both groups will undergo Koshthashodhana with Eranda Taila prior to oral medication. Group A will receive Rasna Panchaka Ghana Vati, while Group B will receive Trayodashanga Guggulu for four weeks, followed by a four-week follow-up period.
The primary outcome measure is improvement in pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include assessment of pain, stiffness, and physical function using the WOMAC index, subjective Ayurvedic parameters, quality of life (SF-36), and inflammatory markers such as ESR and CRP. The study aims to generate evidence-based data on the comparative efficacy and safety of these Ayurvedic formulations and contribute to integrative management strategies for 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
- 31.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patient representing sign and symptoms Of Janu Sandhigata Vata 2.Patient aged between 31-60 years irrespective of sex and occupation 3.Patient willing to participate.
排除标准
- •1.Severe deformity or end-stage OA,Grade IV radiological changes.
- •2.Patients with uncontrolled systemic illnesses such as diabetes HBA1C more than 8, hypertension systolic BP more than 160mmhg and diastolic more than 100mmhg 3.Pregnant and lactating women 4.Secondary osteoarthritis due to trauma, infection, or metabolic disorders.
研究者
Dr Bushra Siddiqui
All India Institute Of Ayurveda
