A Clinical Study to Evaluate the Therapeutic Efficacy of Saghrita Ksheer Basti in the Management of Asthi Majjagata Vata with Special Reference to Avascular Necrosis of Hip Joint
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
- To assess the effect of Saghrita Ksheer Basti on subjective and objective parameters such as pain muscle strength joint mobility and functional capacity in patients of avascular necrosis of hip joint with clinical features of Asthi Majjagata Vata
研究概览
简要总结
This is an open label single arm exploratory clinical study to evaluate the therapeutic efficacy of Saghrita Ksheer Basti in the management of Asthi Majjagata Vata with special reference to Avascular Necrosis of the hip joint AVN A total of 30 patients between the age group of 20 to 60 years having clinical features of Asthi Majjagata Vata and confirmed diagnosis of AVN based on radiological investigations will be included The selected patients will be treated with Saghrita Ksheer Basti in Yapana Basti pattern for 16 days The effect of therapy will be assessed based on subjective parameters such as pain walking ability and muscle strength using Visual Analogue Scale VAS and Harris Hip Score as well as objective parameters including radiographic findings The study aims to evaluate the potential of Ayurvedic enema therapy in reducing symptoms and improving the quality of life in patients suffering from AVN of the hip joint
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged between 20 to 60 years Presence of clinical signs and symptoms consistent with Asthi Majjagata Vata as described in classical Ayurvedic texts Confirmed diagnosis of Avascular Necrosis AVN of the hip joint based on clinical evaluation and supported by radiological investigations such as Xray MRI or CT scan Patients assessed to be eligible for Basti Karma Ayurvedic enema therapy Patients who are willing to participate and provide informed written consent.
排除标准
- •Patients below the age of 20 years and above the age of 60 years Patients having uncontrolled systemic diseases like hypertension diabetes mellitus active neoplastic diseases etc Participants with conditions mimicking AVN such as inflammatory arthritis Potts spine bone tuberculosis traumatic injury or bone tumors Participants with contraindications to the treatment being evaluated such as Saghrita Ksheer Basti Pregnant and lactating women Patients having stage four of avascular necrosis AVN.
结局指标
主要结局
To assess the effect of Saghrita Ksheer Basti on subjective and objective parameters such as pain muscle strength joint mobility and functional capacity in patients of avascular necrosis of hip joint with clinical features of Asthi Majjagata Vata
时间窗: 31 DAYS
次要结局
- The secondary outcome includes observing any(other effects of the drug & procedure, such as)