A Comparative Clinical Study To Evaluate The Efficacy Of Matra Basti With Asthisandhanak Tail (Kalpit Yoga) And Asthishrinkhala Ghan Vati In The Management Of Asthikshaya (Post Menopausal Osteoporosis)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in subjective and objective parameters of asthikshaya including bone mineral density after sixteen days of treatment
研究概览
简要总结
This clinical study is designed to evaluate the efficacy of Matra Basti with Asthisandhanak Taila and Asthishrinkhala Ghan Vati in the management of Asthikshaya, specifically postmenopausal osteoporosis. Osteoporosis is a common degenerative condition in postmenopausal women characterized by decreased bone mass and increased risk of fractures. The study is an open-label, prospective, two-arm, interventional trial conducted on 60 female patients aged between 45 and 65 years having BMD T-score less than minus one and symptoms of Asthikshaya.
Group A will receive Matra Basti with Asthisandhanak Taila 60 ml per day for 16 days. Group B will receive Asthishrinkhala Ghan Vati, 2 tablets of 500 mg twice daily for 16 days. The primary objective is to assess clinical improvement based on subjective and objective parameters, including BMD. Secondary outcome includes improvement in overall quality of life. Patients will be selected from the OPD and IPD of PG Department of Panchakarma, DSRRAU, Jodhpur. Ethical clearance will be obtained, and informed consent will be taken from each participant.
The study aims to explore the comparative efficacy of Ayurvedic basti therapy and oral herbal formulation in strengthening asthi dhatu and preventing osteoporotic complications in postmenopausal women.
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
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged between 45 and 65 years who have Bone Mineral Density T score less than minus one and present with clinical features of osteoporosis asthikshaya or asthi majjagata vata will be included in the study.
排除标准
- •Patients aged below 45 years or above 65 years and patients suffering from rheumatoid arthritis gouty arthritis or other longstanding systemic disorders will be excluded from the study Patients with diabetes mellitus uncontrolled hypertension thyrotoxicosis hyperparathyroidism Addisons disease Pagets disease Cushings syndrome tuberculosis of bone osteomalacia chronic renal disease hepatic failure or cardiac failure will also be excluded.
结局指标
主要结局
Change in subjective and objective parameters of asthikshaya including bone mineral density after sixteen days of treatment
时间窗: 16 days
次要结局
- Improvement in quality of life and observation of any additional therapeutic effects or adverse effects during and after treatment(16 days)
研究者
Dr Asha Meena
Post Graduate Institute of Ayurved