clinical evaluation of abhadya chura and mukta bhasma in the management of Osteopenia/osteoporosis(Ashthi Kshaya)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in quality of life index,
研究概览
简要总结
Asthi kshaya is a condition in which there is decrease in the Asthi dhatu (Bone tissue) leading to many undesirable effects. It can be compared with Osteoporosis in which there is decrease in the Bone Mineral Density (BMD) leading to increased risk of fractures. The Primary aim of the study is to stop further loss of mineral density of bone and to development of ossification through the compound formulations projected, since which has probable effect of Osteogenic effect which can be experimented in the different studies. MuktaSukti Bhasma (Ref- AFI Part-I Page-238- 239) has been experimented is natural source of rich calcium widely used in Traditional system of Indian medicine as a supplement in the treatment of Bone metabolic disorder associated with calcium deficiency.(Ref.Pharmacological Research Volume 48,Issue-6,December 2003,Pages 593-599).Sudha barga compounds having therapeutically rich in calcium (Ref-International journal of Pharmacy ISSN-2230-8407).However the compound effect of Abhadya churna has not been taken into study neither or not experimented so far. But it has been indicated for Majjagata Vata(Bone marrow related) disorder. (Ref- AFI –Part-III ,VOl-1but the all the individual ingredients of Abhadya churna have already been proven to be efficacious in bone marrow related disorder or improvement of bone health.Abhadya churna content The Hypothesis of evaluating the Osteogenic effect from both the combinations, it has been decided to take a study of both the combined formulations i.e. Abhadya Churna and Prabal Bhasma in selected cases of Osteoporosis/Osteopenia*(Asthi Kshaya*). The results will be assessed as per the standard guidelines. It is a prospective clinical trial of classical Ayurveda medicine used in osteopenia since long. It is effort to create evidence of Ayurveda medicine and access the safety and efficacy of trial drug in osteopenia . The project was funded by CCRAS. Special CRF was prepared and NABH accredited laboratory selected to conduct the test. Both subjective and objective parameters will compared with base line and after 12 weeks of treatment. The primary objective to note the quality of life index(QUALEFF0-41)
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
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •BMD T score less than -1.
排除标准
- •fragidity of bone, endocrine dis0rders,patients having poorly controlled hypertension, serum calcium less than 2.6 and more than 10.5 mg/dl.
结局指标
主要结局
change in quality of life index,
时间窗: 12 weeks
次要结局
- change BMD Tscore, Bone specific alkaline phospatase change(12 weeks)
