A randomised controlled clinical study to evaluate the efficacy of Panchatikta ksheera basti with ayurvedic preparation in the management of Asthikshaya with respect to Osteopenia / osteoporosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in functional and physical activities of the patients with improved daily lifestyle
研究概览
简要总结
This study is undertaken to check the role of Panchatikta ksheera basti and ayurvedic preparation in the management of the disease condition of Asthikshaya ( osteoporosis) with pathological investigations before and after. The total duration of the study is 30 days.
Enrollment of the patients will be done after CTRI registration
The Total no of 30 Patients enrolled in the study .
Group A was administered with Panchatikta Ksheera Basti and Praval Panchamruta 250 mg BD for 30 days with initial deepana -pachana drugs for 3 days. Out of which 3 patients were considered dropout as they discontinued the follow up. Group B was given with Organic Calcium Supplement+D3 orally for 30 days. 1 patient was considered dropout in Group B due to irregular follow up. Total 26 patients completed the study
The results statistically showed better results in Group A than in Group B in some parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with classical sign and symptoms of of asthikshaya like asthishula, toda, sandhi shaithilya, kesha, loma, nakha, danta vikara and patana, daurbalya, rukshata etc.
- •Osteopenic /Osteoporotic patients of either gender whose BMD (t score) is equal to or less than -1.
排除标准
- •1.Patients suffering from neoplasm of bone.
- •2.Known case of Diabetes Mellitus, Thyrotoxicosis, Hyper Parathyroidism, Addison’s disease, Paget’s disease, Cushing’s syndrome, Tuberculosis of bone , Osteomalacia, Chronic renal, Hepatic, cardiac failure 3.Rheumatoid Arthritis, Gouty Arthritis and any other long standing systemic disorders.
结局指标
主要结局
Improvement in functional and physical activities of the patients with improved daily lifestyle
时间窗: 30 days
次要结局
- Improvement in their daily lifestyle(30 days)